510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2016
TOTAL 510(k)s THIS PERIOD 239
TOTAL WITH SUMMARIES 224
TOTAL WITH STATEMENTS 15
DEVICE: Applanation Tonometer
SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional)
ATTN: Weida Zhan PHONE NO : 8621 542 60421
Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16
SHANGHAI CN 200237 510(k) STATEMENT
DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Sugentech, Inc. 510(k) NO: K142754(Traditional)
ATTN: Mijin Sohn PHONE NO : 82 42 3645001
Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-APR-16
Daejeon KR 305-811 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination gloves, Powderfree, Blue color
PRIMUS GLOVES PVT LIMITED 510(k) NO: K143477(Traditional)
ATTN: JOSE PAUL M PHONE NO : 91 484 2413063
PLOT No: 14-A, COCHIN SPECIAL ECONSE DECISION MADE: 14-APR-16
COCHIN IN 682037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUE METRIX GO Self Monitoring Blood Glucose System
Trividia Health, Inc. 510(k) NO: K143548(Traditional)
ATTN: Beth Foster PHONE NO : 1 954 6779201 3044
2400 NW 55TH COURT SE DECISION MADE: 01-APR-16
Fort Lauderdale FL 33309 510(k) STATEMENT
DEVICE: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
GLOBUS MEDICAL INC. 510(k) NO: K143578(Traditional)
ATTN: KELLY J BAKER PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 13-APR-16
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutraseb Facial Cream
ISDIN Corp 510(k) NO: K143605(Traditional)
ATTN: STEVE SMITH PHONE NO : 609 3752140
100 Overlook Center 2nd Floor SE DECISION MADE: 14-APR-16
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeCare PCA Infusion System
Hospira, Inc 510(k) NO: K143612(Traditional)
ATTN: Tom Gutierrez PHONE NO : 1 858 3911142
275 North Field Drive SE DECISION MADE: 08-APR-16
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ekso? (version 1.1) and Ekso GT? (version 1.2)
EKSO BIONICS, INC. 510(k) NO: K143690(Traditional)
ATTN: JOHN TUGWELL PHONE NO : 1 510 5292537
1414 HARBOUR WAY SOUTH, SUITE 1201SE DECISION MADE: 01-APR-16
RICHMOND VA 94804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERASENSE Knee System
OrthoSensor, Inc. 510(k) NO: K150372(Traditional)
ATTN: Kimberlee Washburn PHONE NO : 954 5777770
1855 Griffin Road, Suite A-310 SE DECISION MADE: 15-APR-16
Dania Beach FL 33004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectra S1Plus and Spectra S2 Plus
UZINMEDICARE CO. 510(k) NO: K150476(Traditional)
ATTN: Ho Jun Kang PHONE NO : 82 31 7395270
Rm 105, Joongang Induspia V, SagimSE DECISION MADE: 15-APR-16
Jungwon-gu KR 462-807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blockade Surgical Gown
Medline Industries, Inc. 510(k) NO: K150598(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
One Medline Place SE DECISION MADE: 28-APR-16
Mundelein IL 60060 510(k) STATEMENT
DEVICE: Dash-Topic Plus Cream
Founders Science Group, LLC 510(k) NO: K150914(Traditional)
ATTN: Ronald M Gurge PHONE NO : 401 2168077 702
400 Highland Corporate Drive SE DECISION MADE: 21-APR-16
Cumberland RI 02864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orbit Infusion Set
YPSOMED AG 510(k) NO: K150921(Traditional)
ATTN: STEPHAN AFFOLTER PHONE NO : 0041 34 4243382
BRUNNMATTSTRASSE 6 SE DECISION MADE: 12-APR-16
BURGDORF CH CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ManoScan System
GIVEN IMAGING LTD. 510(k) NO: K151086(Traditional)
ATTN: HILLA DEBBY PHONE NO : 972 4 9097774
2 HACARMEL ST. NEW INDUSTRIAL PARKSE DECISION MADE: 28-APR-16
YOQNEAM IL 20962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simple T Pediatric Nasal Mask
RESPIRONICS, INC. 510(k) NO: K151120(Abbreviated)
ATTN: SHAYLEE MASILUNAS PHONE NO : 724 3877729
1001 MURRY RIDGE LANE SE DECISION MADE: 15-APR-16
MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiagon Navigation System
FIAGON GMBH 510(k) NO: K151156(Traditional)
ATTN: DIRK MUCHA PHONE NO : 49 3302 2012124
NEUENDORFSTRASSE 23B SE DECISION MADE: 01-APR-16
HENNIGSDORF DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRI TL
AT MEDICAL UAB 510(k) NO: K151357(Traditional)
ATTN: THOMAS PEDERSEN PHONE NO : 00 452 6340702
DRAUGYSTES G.19 SE DECISION MADE: 22-APR-16
KAUNAS LT 51230 510(k) STATEMENT
DEVICE: ARCHITECT ROMA
Fujirebio Diagnostics, Inc. 510(k) NO: K151502(Traditional)
ATTN: Diana Dickson PHONE NO : 610 2403917
201 Great Valley Parkway SE DECISION MADE: 28-APR-16
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
GBUK Enteral Limited 510(k) NO: K151503(Traditional)
ATTN: Mark Thompson PHONE NO : 44 17572 82945
Blackwood Hall Business Park, NortSE DECISION MADE: 05-APR-16
Selby GB YO85DD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers CA Heads and Adapters
ARTHREX, INC. 510(k) NO: K151527(Traditional)
ATTN: COURTNEY SMITH PHONE NO : 239 6435553 71720
1370 CREEKSIDE BOULEVARD SE DECISION MADE: 19-APR-16
NAPLES FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: maxFit II Dental Implant System
Taiwan Implant Technology Company,510(k) NO: K151588(Traditional)
ATTN: Ching-Chieh Huang PHONE NO : 886 7 6955561
Kaohsiung Science Park Branch 5F.,SE DECISION MADE: 25-APR-16
Kaohsiung TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4plus6Line Abutment System
OT MEDICAL GMBH 510(k) NO: K151608(Traditional)
ATTN: Martina Behlau PHONE NO : 49 421 55716115
KONSUL-SMIDT-STR. 8B SE DECISION MADE: 13-APR-16
BREMEN DE D-28217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTez elastomeric infusion pump
Epic Medical Pte Ltd 510(k) NO: K151650(Third Party – Traditional)
ATTN: Freddie Lee PHONE NO : 65 9635 2618
545 Orchard Road, #09-0 SE DECISION MADE: 04-APR-16
Singapore SG 238882 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SleepWeaver Advance Pediatric Nasal CPAP Mask
Circadiance, LLC 510(k) NO: K151683(Traditional)
ATTN: David Groll PHONE NO : 724 8582837
1060 Corporate Lane SE DECISION MADE: 05-APR-16
Export PA 15632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diplomat® Spinal System
SIGNUS Medizintechnik GmbH 510(k) NO: K151704(Traditional)
ATTN: Jochim Schneider PHONE NO : 49 6023 9166213
Industriestr. 2 SE DECISION MADE: 13-APR-16
Alzenau DE 63755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rainbow Paste Stain
GENOSS 510(k) NO: K151731(Traditional)
ATTN: BYUNGSUN KIM PHONE NO : 82 31 8885100
105 GWANGGYO-RO, YEONGTONG-GU 1F, SE DECISION MADE: 15-APR-16
SUWON-SI KR 443-270 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
SURGICAL LASER INCORPORATED 510(k) NO: K151855(Traditional)
ATTN: GORDON WILLOX PHONE NO : 905 7170508
SUITE 337 7950 NW 53RD STREET SE DECISION MADE: 15-APR-16
MIAMI FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
Salter Labs 510(k) NO: K151874(Traditional)
ATTN: Mara Caler PHONE NO : 760 7957094
2365 Camino Vida Roble SE DECISION MADE: 15-APR-16
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noris Medical Zygomatic Dental Implant System
NORIS MEDICAL LTD. 510(k) NO: K151909(Traditional)
ATTN: SIMHA SIBONY PHONE NO : 972 73 7964477
8 HATAASIA SE DECISION MADE: 08-APR-16
NESHER IL 3688808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM-Thin Client (mobile)
MIM Software Inc. 510(k) NO: K151913(Traditional)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive SUITE 180SE DECISION MADE: 25-APR-16
CLEVELAND OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimSox(TM) System
StimMed, LLC 510(k) NO: K151922(Traditional)
ATTN: Robert E Kaplan PHONE NO : 716 4356736
388 Evans Street SE DECISION MADE: 15-APR-16
Williamsville NY 14221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
A&D COMPANY, LTD 510(k) NO: K151953(Traditional)
ATTN: JERRY WANG PHONE NO : 408 5185113
1756 AUTOMATION PARKWAY SE DECISION MADE: 13-APR-16
SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
Merit Medical Systems, Inc. 510(k) NO: K151967(Traditional)
ATTN: Susan Christensen PHONE NO : 801 2084789
1600 West Merit Parkway SE DECISION MADE: 04-APR-16
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icotec Pedicle System
ICOTEC AG 510(k) NO: K151977(Traditional)
ATTN: JORG SCHNEIDER PHONE NO : 41 71 7570001
INDUSTRIESTRASSE 12 SE DECISION MADE: 12-APR-16
ALTSTAETTEN SE 9450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin LSS Plating System
KLS MARTIN L.P. 510(k) NO: K151983(Traditional)
ATTN: JENNIFER DAMATO PHONE NO : 800 6251557
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 06-APR-16
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
INOVA DIAGNOSTICS, INC. 510(k) NO: K152013(Traditional)
ATTN: Gabriella Lakos PHONE NO : 858 5869900 1393
9900 OLD GROVE ROAD SE DECISION MADE: 11-APR-16
SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Winco Model S550 Stretchair
WINCO MANUFACTURING LLC 510(k) NO: K152056(Traditional)
ATTN: JAMES ANKOVIAK PHONE NO : 800 2373377
5516 SOUTHWEST 1ST LANE SE DECISION MADE: 11-APR-16
OCALA FL 34474 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable General Electrode
MODERN MEDICAL EQUIPMENT MANUFACTU510(k) NO: K152059(Traditional)
ATTN: THOMAS CHAN TSZ FUNG PHONE NO : 852 24209068
35-41 TAI LIN PAI RD., UNIT F, 5THSE DECISION MADE: 21-APR-16
HONG KONG TW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Ertapenem (<=0.12 – >=8 ug/mL)
bioMerieux, Inc 510(k) NO: K152075(Traditional)
ATTN: Cherece L Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 15-APR-16
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxiGen
HANS BIOMED CORP. 510(k) NO: K152077(Traditional)
ATTN: LUCY CHOI PHONE NO : 82 2 4662266
64, YUSEONG-DAERO 1628 BEON-GIL, YSE DECISION MADE: 21-APR-16
DAEJEON KR 305-811 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
CORENTEC CO., LTD 510(k) NO: K152084(Traditional)
ATTN: J S Daniel PHONE NO : 82 41 5857144
12, YEONGSANHONG 1-GIL, IPJANG-MYESE DECISION MADE: 29-APR-16
CHEONAN-SI KR 331-822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3Shape Ortho System
3Shape A/S 510(k) NO: K152086(Traditional)
ATTN: Hanne Nielsen PHONE NO : 45 7027 2620
Holmens Kanal 7 SE DECISION MADE: 28-APR-16
Copenhagen DK DK-1060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthChek Network Health Station
HEALTHCHEK NETWORK, LLC 510(k) NO: K152107(Traditional)
ATTN: JAMES EVANS PHONE NO : 608 3206361
135 WEST SALLIER STREET SE DECISION MADE: 12-APR-16
LAKE CHARLES LA 70601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symmetry Surgical Quad-Lock Container System
SYMMETRY SURGICAL INC. 510(k) NO: K152111(Traditional)
ATTN: LORA TJOMSTOL PHONE NO : 1 800 2513000
334 OWEN DRIVE SE DECISION MADE: 14-APR-16
ANTIOCH TN 37013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dropper hsCRP High Sensitivity CRP Control
Quantimetrix Corporation 510(k) NO: K152117(Traditional)
ATTN: Kaylna Snylyk PHONE NO : 310 5360006
2005 Manhattan Beach Blvd SE DECISION MADE: 21-APR-16
Redondo Beach CA 90278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagView BIOMAGNETOMETER SYSTEM
TRISTAN TECHNOLOGIES, INC 510(k) NO: K152184(Traditional)
ATTN: KEVIN PRATT PHONE NO : 858 5502700
6191 CORNERSTONE CT., STE 107 SE DECISION MADE: 08-APR-16
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: transGlide Expandable Introducer
TRANSAORTIC MEDICAL, INC. 510(k) NO: K152194(Traditional)
ATTN: RICHARD GINN PHONE NO : 408 7794200
135 E. MAIN AVE., SUITE 170 SE DECISION MADE: 07-APR-16
MORGAN HILL CA 95037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
GMP MEDICARE SDN BHD (F25) 510(k) NO: K152222(Traditional)
ATTN: MS.EVA VINONI MUSTAFA PHONE NO : 603 33926317
LOT/PT64593,JLN DAHLIA/KU8,KAW PERSE DECISION MADE: 21-APR-16
KLANG MY 41050 510(k) STATEMENT
DEVICE: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
OXYHEAL MEDICAL SYSTEMS, INC. 510(k) NO: K152223(Traditional)
ATTN: Edward J Chomas PHONE NO : 619 3362022
3224 HOOVER AVE. SE DECISION MADE: 29-APR-16
National City CA 91950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Cortisol II, Cortisol II CalSet
ROCHE DIAGNOSTICS 510(k) NO: K152227(Traditional)
ATTN: KELLI TURNER PHONE NO : 317 5214515
9115 HAGUE ROAD SE DECISION MADE: 27-APR-16
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hydroven 12, Hydroven 12 Garments
HUNTLEIGH HEALTHCARE LTD 510(k) NO: K152228(Traditional)
ATTN: GREG BAILY PHONE NO : 44 2920 485885
35 PORTMANMOOR ROAD SE DECISION MADE: 04-APR-16
CARDIFF GB CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBS iNsight
MEDIMAPS GROUP SA 510(k) NO: K152299(Traditional)
ATTN: CHRISTOPHE LELONG PHONE NO : 41 22 8848644
18, CHEMIN DES AULX SE DECISION MADE: 29-APR-16
PLAN LES OUATES CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden Afib Detection Program QP-039P
NIHON KOHDEN CORPORATION 510(k) NO: K152305(Abbreviated)
ATTN: TOM BENTO PHONE NO : 949 2687708
1-31-4 NISHIOCHIAI, SHINJUKU-KU SE DECISION MADE: 08-APR-16
TOKYO JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
C2 Therapeutics, Inc. 510(k) NO: K152329(Traditional)
ATTN: Theresa Brandner-Allen PHONE NO : 650 5215921
303 Convention Way, Suite 1 SE DECISION MADE: 13-APR-16
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
PC Marketing, Inc. 510(k) NO: K152364(Traditional)
ATTN: Michael Rolls PHONE NO : 201 9436100
1040 Wilt Avenue SE DECISION MADE: 14-APR-16
Ridgefield NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
AgaMatrix, Inc. 510(k) NO: K152365(Traditional)
ATTN: David Olsen PHONE NO : 603 3286049
7C Raymond Avenue SE DECISION MADE: 21-APR-16
Salem NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-32;T-40;T-44;T-52;T-72;TT-50
Tanses Technologies inc. 510(k) NO: K152412(Traditional)
ATTN: Kirk Kiremitci PHONE NO : 450 6224004
4450 Highway 13 SE DECISION MADE: 29-APR-16
Fabreville CA H7R 6E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: All Poly Tibial Component
UNITED ORTHOPEDIC CORPORATION 510(k) NO: K152430(Traditional)
ATTN: KAREN HO PHONE NO : 886 3 5773351 2212
NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 12-APR-16
HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U2 Bipolar Implant and 22mm Femoral Head
UNITED ORTHOPEDIC CORPORATION 510(k) NO: K152439(Traditional)
ATTN: Karen Ho PHONE NO : 886 35 773351 2212
NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 07-APR-16
HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemiCAP MTP Resurfacing Hemi-Arthroplasty System
ARTHROSURFACE, INC. 510(k) NO: K152454(Special)
ATTN: DAWN J. WILSON PHONE NO : 508 5203003
28 FORGE PARKWAY SE DECISION MADE: 11-APR-16
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HG Pro Nitrile Powder Free Examination Gloves
HEALTHY GLOVE CO.,LTD 510(k) NO: K152479(Traditional)
ATTN: TEOH CHOH SHEE PHONE NO : 66 74 536815
119 Kanchanavanich Road, Tambol PaSE DECISION MADE: 04-APR-16
Hat Yai TH 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POGO Automatic Blood Glucose Monitoring System
INTUITY MEDICAL, INC 510(k) NO: K152493(Traditional)
ATTN: Robb Hesley PHONE NO : 408 5301711
526 Almanor Avenue SE DECISION MADE: 25-APR-16
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JRP Wound Spreader
J.R. PARKER, LLC 510(k) NO: K152538(Traditional)
ATTN: J RICHARD PARKER PHONE NO : 484 4103592
1665 WARPATH ROAD SE DECISION MADE: 13-APR-16
WEST CHESTER PA 19382 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
EDAN INSTRUMENTS, INC. 510(k) NO: K152552(Traditional)
ATTN: QUEENA CHEN PHONE NO : 86 755 26858736
3/F – B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 29-APR-16
SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CueSee Hypoxic
EUROTROL B.V. 510(k) NO: K152553(Traditional)
ATTN: Paul Kooijmans PHONE NO : 31 318 695777
KEPLERLAAN 20 SE DECISION MADE: 22-APR-16
EDE NL 6716 BS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter (MD300M/MD300K2)
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K152563(Traditional)
ATTN: LEI CHEN PHONE NO : 86 10 88798300 6020
NO.9 SHUANGYUAN ROAD, BADACHU HI-TSE DECISION MADE: 18-APR-16
BEIJING CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeGlobal Micro Tips
LifeGlobal Group, LLC 510(k) NO: K152581(Traditional)
ATTN: Michael D. Cecchi PHONE NO : 203 4531700
393 Soundview Road SE DECISION MADE: 11-APR-16
Guilford CT 06437 510(k) STATEMENT
DEVICE: ACCU NEWS Drug Screening Test Card/Urine Cup
CORETESTS, INC 510(k) NO: K152590(Traditional)
ATTN: ERIC SUN PHONE NO : 858 3331122
6190 YARROW DRIVE SE DECISION MADE: 15-APR-16
CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neoscope 3D – 3D Digital Video Endoscopic System (Rigid/Flexible)
PROSURG, INC. 510(k) NO: K152619(Traditional)
ATTN: ASHVIN DESAI PHONE NO : 408 9454044
2193 TRADE ZONE BLVD. SE DECISION MADE: 29-APR-16
SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
GAIA DENTAL PRODUCTS, INC. 510(k) NO: K152652(Traditional)
ATTN: WEITAO JIA PHONE NO : 203 2381181
290 PRATT ST, UNIT 2314 SE DECISION MADE: 05-APR-16
MERIDEN CT 06450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StrataMR Valves and Shunts
MEDTRONIC NEUROSURGERY 510(k) NO: K152700(Traditional)
ATTN: Micah Schloss PHONE NO : 805 5718584
125 CREMONA DRIVE SE DECISION MADE: 07-APR-16
GOLETA CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matrix Mini ECG Monitor
GLOBAL INSTRUMENTATION, LLC 510(k) NO: K152701(Abbreviated)
ATTN: CRAIG SELLERS PHONE NO : 315 6820272 120
8104 CAZENOVIA ROAD SE DECISION MADE: 22-APR-16
MANLIUS NY 13104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
ADVANCED VISION TECHNOLOGIES 510(k) NO: K152724(Traditional)
ATTN: KEITH PARKER PHONE NO : 888 3935374
969 SOUTH KIPLING PARKWAY SE DECISION MADE: 27-APR-16
LAKEWOOD CO 80226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISEN-Goggles
ISEN TECH & TRADING COMPANY, LTD. 510(k) NO: K152727(Traditional)
ATTN: MARTIN LIU PHONE NO : 86 10 51267072
RM509, BLDG A, CYBER TOWER, NO. 2 SE DECISION MADE: 26-APR-16
BEIJING CN 100086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytosponge Cell Collection Device
Covidien LLC 510(k) NO: K152794(Traditional)
ATTN: Clare Santulli PHONE NO : 408 3287383
15 Hampshire Street SE DECISION MADE: 12-APR-16
Mansfield MA 020408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREFOIL System
NOBEL BIOCARE AB 510(k) NO: K152836(Traditional)
ATTN: CHARLEMAGNE CHUA PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNGASE DECISION MADE: 11-APR-16
GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merge Hemo
MERGE HEALTHCARE INCORPORATED 510(k) NO: K152864(Traditional)
ATTN: MIKE DIEDRICK PHONE NO : 262 9123570
900 WALNUT RIDGE DRIVE SE DECISION MADE: 07-APR-16
HARTLAND WI 53029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
SPACELABS HEALTHCARE LTD. 510(k) NO: K152881(Traditional)
ATTN: AL VAN HOUDT PHONE NO : 44 199 2507730
1 HARFORDE COURT JOHN TATE ROAD SE DECISION MADE: 01-APR-16
HERTFORD GB SG13 7NW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System
INTUITIVE SURGICAL 510(k) NO: K152892(Traditional)
ATTN: Crystal Ong PHONE NO : 408 5238636
1266 KIFER ROAD SE DECISION MADE: 29-APR-16
SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVIVAL(TM) Modular Revision Hip Stem
CORIN USA 510(k) NO: K152903(Traditional)
ATTN: DIANA L. NADER-MARTONE PHONE NO : 813 9774469
5670 W CYPRESS STREET SE DECISION MADE: 29-APR-16
TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRILLIANT EVERGLOW
COLTENE/WHALEDENT AG 510(k) NO: K152927(Traditional)
ATTN: SILKE WALLASCHEK PHONE NO : 41 717 575852
FELDWIESENTR. 20 SE DECISION MADE: 28-APR-16
ALTSTATTEN CH 9450 510(k) STATEMENT
DEVICE: MMS PTA Balloon Catheter
MicroMedical Solutions, Inc. 510(k) NO: K152934(Traditional)
ATTN: Gregory Mathison PHONE NO : 218 3871559
790 Willard Street #209 SE DECISION MADE: 25-APR-16
Quincy MA 02169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Temporary Pacing Cable
TIGER MEDICAL PRODUCTS 510(k) NO: K152947(Traditional)
ATTN: Veronica Lee PHONE NO : 404 6966999
JAJE PLAZA, SUITE 703, 1717 NORTH SE DECISION MADE: 05-APR-16
Shanghai CN 200080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
Sybron Dental Specialties 510(k) NO: K152959(Special)
ATTN: Courtney Clark PHONE NO :
1717 W. Collins Ave SE DECISION MADE: 14-APR-16
Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dyna-Vision Telemonitoring System
Techmedic Development Internationa510(k) NO: K152973(Traditional)
ATTN: Rutger Brest van Kempen PHONE NO : 31 0226 342044
Broeker Werf 6 SE DECISION MADE: 29-APR-16
Broek op Langedijk NL 1721 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioMonitor 2-AF, BioMonitor 2-S
BIOTRONIK, INC. 510(k) NO: K152995(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 JEAN ROAD SE DECISION MADE: 11-APR-16
LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA Telescopes
OLYMPUS, WINTER & IBE GMBH 510(k) NO: K153009(Traditional)
ATTN: Katharina Schnackenburg PHONE NO : 49 406 69662997
KUEHNSTR. 61 SE DECISION MADE: 05-APR-16
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobius3D
MOBIUS MEDICAL SYSTEMS, LP 510(k) NO: K153014(Traditional)
ATTN: STAN ESHELMAN PHONE NO : 888 2638541
5012 Tamarisk St SE DECISION MADE: 29-APR-16
Bellaire TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
MEDTRONIC, INC. 510(k) NO: K153038(Special)
ATTN: NISARG SHAH PHONE NO : 978 7396632
37A CHERRY HILL DRIVE SE DECISION MADE: 13-APR-16
DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noris Medical MBI Dental Implant System
NORIS MEDICAL LTD. 510(k) NO: K153043(Traditional)
ATTN: Simha Sibony PHONE NO : 972 737 964477
8 HATAASIA SE DECISION MADE: 11-APR-16
NESHER IL 3688808 510(k) STATEMENT
DEVICE: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Co-Innovation Biotech Co., Ltd 510(k) NO: K153050(Special)
ATTN: Hong Feng PHONE NO : 86 20 62867285
No. 13, Yanyuan Road, Tianhe DistrSE DECISION MADE: 26-APR-16
Guangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Juno VPAP ST-A
RESMED LTD 510(k) NO: K153061(Traditional)
ATTN: Jean-Nicolas BOUDAUD PHONE NO : 61 288 841000
1 Elizabeth Macarthur Drive SE DECISION MADE: 13-APR-16
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
Teleflex Medical, Inc. 510(k) NO: K153063(Traditional)
ATTN: HOLLY HALLOCK PHONE NO : 919 4334918
3015 Carrington Mill Blvd SE DECISION MADE: 08-APR-16
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio Zygomatic Implant System
BLUE SKY BIO, LLC 510(k) NO: K153064(Traditional)
ATTN: Michele Vovolka PHONE NO : 1 718 3760422
888 E BELVIDERE RD. SUITE 212 SE DECISION MADE: 29-APR-16
GRAYSLAKE IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nephros S100
NEPHROS INC. 510(k) NO: K153084(Traditional)
ATTN: JAMES SUMMERTON PHONE NO : 201 3435202
41 GRAND AVE SE DECISION MADE: 08-APR-16
River Edge NJ 07661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRMap Catheter
ABBOTT ELECTROPHYSIOLOGY 510(k) NO: K153093(Traditional)
ATTN: DENNIS POZZO PHONE NO : 314 3006580
1530 OBRIEN DRIVE SUITE B SE DECISION MADE: 07-APR-16
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLOCKNER VEGA DENTAL IMPLANT SYSTEM
SOADCO, S.L. 510(k) NO: K153098(Abbreviated)
ATTN: MARIA MITJANETA PHONE NO : 376 800 590
AVGDA. FITER I ROSELL., 4 BIS-LOCASE DECISION MADE: 08-APR-16
ESCALDES-ENGORDANY AD AD-700 510(k) STATEMENT
DEVICE: Genesys Spine Apache Interbody Fusion System
GENESYS SPINE 510(k) NO: K153123(Traditional)
ATTN: Dave Lamb PHONE NO : 512 3817094
1250 SOUTH CAPITOL OF TEXAS HIGHWASE DECISION MADE: 26-APR-16
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syzygy Stabilization System
AMENDIA, INC. 510(k) NO: K153152(Traditional)
ATTN: Kristen Allen PHONE NO : 877 7553329
1755 WEST OAK PARKWAY SE DECISION MADE: 27-APR-16
MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReGrasp
Rehabtronics Inc. 510(k) NO: K153163(Traditional)
ATTN: Mike Pearson PHONE NO : 1 780 6382520
#4532, 10230 Jasper Avenue SE DECISION MADE: 07-APR-16
Edmonton CA T5J 4P6 510(k) STATEMENT
DEVICE: Bi-Blade Vitrectomy Cutter
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K153168(Special)
ATTN: Brenda Balletto PHONE NO : 510 3573952 140
557 MCCORMICK STREET SE DECISION MADE: 29-APR-16
SAN LEANDRO CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ketac Universal Aplicap
3M DEUTSCHLAND GMBH 510(k) NO: K153174(Traditional)
ATTN: RUEDIGER FRANKE PHONE NO : 49 8152 7001802
ESPE PLATZ SE DECISION MADE: 13-APR-16
SEEFELD DE 82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
Chemtron Biotech, Inc. 510(k) NO: K153192(Traditional)
ATTN: Jane Zhang PHONE NO : 858 4500044
9245 Brown Deer Road SE DECISION MADE: 18-APR-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOVIEW HemoPro Endoscopic Vessel Harvesting System
MAQUET CARDIOVASCULAR, LLC 510(k) NO: K153194(Traditional)
ATTN: MARK DINGER PHONE NO : 973 7097691
45 BARBOUR POND DRIVE SE DECISION MADE: 19-APR-16
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leva Spacer System
SPINE WAVE, INC. 510(k) NO: K153222(Traditional)
ATTN: Gail Yaeker-Daunis PHONE NO : 203 9449494
3 ENTERPRISE DRIVE, SUITE 210 SE DECISION MADE: 15-APR-16
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Superbium
BIOS S.R.L 510(k) NO: K153229(Traditional)
ATTN: Riccardo Pisati PHONE NO : 39 022 7304275
VIA GUIDO ROSSA, 10/12 SE DECISION MADE: 12-APR-16
VIMODRONE IT I-20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulpdent Solo Flowable Composite with MCP
Pulpdent Corporation 510(k) NO: K153249(Traditional)
ATTN: Kenneth J Berk PHONE NO : 1 617 9266666
80 Oakland Street SE DECISION MADE: 01-APR-16
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
NINGBO FREE TRADE ZONE TENSO MEDIC510(k) NO: K153251(Traditional)
ATTN: CHARLES SHEN PHONE NO : 086 574 87344400
24/F, 238 ZHONGSHAN EAST ROAD SE DECISION MADE: 14-APR-16
NINGBO CN 315010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aero Chrome* Breathable Performance Surgical Gown
Halyard Health, Inc. 510(k) NO: K153255(Traditional)
ATTN: DAVID M. LEE PHONE NO : 470 4485182
5405 Windward Parkway SE DECISION MADE: 13-APR-16
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
Surgical Instrument Service and Sa510(k) NO: K153258(Traditional)
ATTN: Brandi J Panteleon PHONE NO : 541 9233310
2747 SW 6th St. SE DECISION MADE: 05-APR-16
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Lightning, TSX-035A/4 and /5, V7.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K153263(Traditional)
ATTN: PAUL BIGGINS PHONE NO : 714 6697808
1385 SHIMOISHIGAMI SE DECISION MADE: 01-APR-16
OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extension Set
B. BRAUN MEDICAL INC. 510(k) NO: K153293(Traditional)
ATTN: Kimberly Smith PHONE NO : 610 5962326
901 MARCON BLVD SE DECISION MADE: 06-APR-16
ALLENTOWN PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
ROCHE DIAGNOSTICS 510(k) NO: K153301(Traditional)
ATTN: EDIE EADS PHONE NO : 317 5214668
9115 HAGUE ROAD SE DECISION MADE: 08-APR-16
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
EYEYON MEDICAL 510(k) NO: K153305(Traditional)
ATTN: MALCA CHEN-ZION PHONE NO : 972 737 803607
GOLDA MEIR 5 SE DECISION MADE: 08-APR-16
NES ZIONA IL 7403649 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K153343(Traditional)
ATTN: JOHN URTZ PHONE NO : 610 4486002
40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 15-APR-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K153361(Traditional)
ATTN: STACEY DOLAN PHONE NO : 610 2403843
201 GREAT VALLEY PARKWAY SE DECISION MADE: 15-APR-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hoffmann LRF (Limb Reconstruction Frame) System
Stryker GmbH 510(k) NO: K153377(Traditional)
ATTN: Paul Nelson PHONE NO : 201 8315691
325 Corporate Drive SE DECISION MADE: 11-APR-16
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Spinal System
ZAVATION, LLC 510(k) NO: K153404(Traditional)
ATTN: Lawrence Walker PHONE NO : 601 9191119
400 LIBERTY PARK DR SE DECISION MADE: 21-APR-16
FLOWOOD MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Neptune 3 Waste Management System
STRYKER CORPORATION 510(k) NO: K153407(Traditional)
ATTN: KIM WIERSEMA PHONE NO : 269 3893584
4100 E. MILHAM AVE SE DECISION MADE: 25-APR-16
KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 430 Torque High-Speed Handpiece Series – 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
DENTALEZ, INC. 510(k) NO: K153411(Traditional)
ATTN: DAN LASKOWITZ PHONE NO : 717 2911161
1816 COLONIAL VILLAGE LANE SE DECISION MADE: 08-APR-16
LANCASTER PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP Spinal System
MEDICREA INTERNATIONAL S.A. 510(k) NO: K153413(Traditional)
ATTN: DAVID RYAN PHONE NO : 33 472 018787
14 PORTE DU GRAND LYON SE DECISION MADE: 22-APR-16
NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive CoRoent Thoracolumbar System
NUVASIVE, INCORPORATED 510(k) NO: K153419(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 LUSK BLVD. SE DECISION MADE: 13-APR-16
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Multislice CT System with Low Dose CT Lung Cancer
PHILIPS MEDICAL SYSTEMS (CLEVELAND510(k) NO: K153444(Traditional)
ATTN: Michael Chilbert PHONE NO : 440 4833284
595 MINER ROAD SE DECISION MADE: 08-APR-16
Cleveland OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC Posterior Spinal Fixation System
Astura Medical 510(k) NO: K153446(Traditional)
ATTN: Troy Taylor PHONE NO : 760 8148047
5670 El Camino Real, Suite B SE DECISION MADE: 08-APR-16
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2008K2 Hemodialysis Machine
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K153449(Traditional)
ATTN: DENISE OPPERMANN PHONE NO : 781 6994479
920 WINTER STREET SE DECISION MADE: 26-APR-16
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inertia Pedicle Screw and Deformity Correxxion System
NEXXT SPINE LLC 510(k) NO: K153453(Traditional)
ATTN: ANDY ELSBURY PHONE NO : 317 4367801
14425 BERGEN BLVD, SUITE B SE DECISION MADE: 26-APR-16
NOBLESVILLE IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDR D-EVO flat Panel Detector System
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K153464(Traditional)
ATTN: Katherine Y. Choi PHONE NO : 203 6023568
419 WEST AVENUE SE DECISION MADE: 08-APR-16
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
BECTON, DICKINSON AND COMPANY 510(k) NO: K153481(Traditional)
ATTN: John Blewitt PHONE NO : 201 8475473
1 BECTON DRIVE SE DECISION MADE: 04-APR-16
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Thoracic Plating System
KLS-MARTIN L.P. 510(k) NO: K153482(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 SAINT JOHNS INDUSTRIAL PARKSE DECISION MADE: 06-APR-16
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affirm Prone Biopsy System
Hologic Inc 510(k) NO: K153486(Traditional)
ATTN: Sarah Fairfield PHONE NO : 508 2638857
36 Apple Ridge Road SE DECISION MADE: 01-APR-16
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bullfrog Micro-Infusion Device
MERCATOR MEDSYSTEMS, INC. 510(k) NO: K153501(Traditional)
ATTN: KIRK P. SEWARD PHONE NO : 510 6144550
2200 POWELL STREET SUITE 530 SE DECISION MADE: 15-APR-16
EMERYVILLE CA 94608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pyrenees Cervical Plate System
K2M 510(k) NO: K153526(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
751 MILLER DRIVE SE SE DECISION MADE: 27-APR-16
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM ENT Navigated Suctions
MEDTRONIC NAVIGATION, INC. 510(k) NO: K153555(Traditional)
ATTN: Carey Brenner PHONE NO : 720 8902185
826 COAL CREEK CIRCLE SE DECISION MADE: 07-APR-16
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventix Suture Anchor
BIOMET MANUFACTURING CORP. 510(k) NO: K153558(Traditional)
ATTN: Adam Cargill PHONE NO : 574 3711006
56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 21-APR-16
WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Glove
Viet Glove Corporation 510(k) NO: K153562(Traditional)
ATTN: Pham Ngoc Thanh PHONE NO : 84 0650 591220
Cau Sat Hamlet, Lai Hung Commune BSE DECISION MADE: 01-APR-16
Bau Bang Province VN 510(k) STATEMENT
DEVICE: Magma System
FORMATEK SYSTEMS LTD. 510(k) NO: K153566(Traditional)
ATTN: AHAVA STEIN PHONE NO : 972 4 8571848
3 HAYOZMA ST. SE DECISION MADE: 06-APR-16
TIRAT HACARMEL IL 3903203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder Scanner
Caresono Technology Co., Ltd. 510(k) NO: K153581(Traditional)
ATTN: Yuzhong Ma PHONE NO : 0086 415 6123779
4th Floor, No.11 Building InitiatiSE DECISION MADE: 08-APR-16
Dangdong TW 118009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioVision Plus
FAXITRON BIOPTICS LLC 510(k) NO: K153583(Special)
ATTN: CARLOS REYES PHONE NO : 520 3998180
3440 E. BRITANNIA DRIVE SUITE 150 SE DECISION MADE: 01-APR-16
TUCSON AZ 85743 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AvaDent Denture Base Material
Global Dental Science 510(k) NO: K153590(Traditional)
ATTN: Chuck Johnson PHONE NO : 480 2752736
15730 N 83rd Way, Suite 101 SE DECISION MADE: 22-APR-16
Scottsdale AZ 85260 510(k) STATEMENT
DEVICE: Materialise Glenoid Positioning System
MATERIALISE NV 510(k) NO: K153602(Traditional)
ATTN: OLIVER CLEMENS PHONE NO : 32 1 6744537
TECHNOLOGIELAAN 15 SE DECISION MADE: 26-APR-16
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphatec Navigation Instruments
ALPHATEC SPINE, INC. 510(k) NO: K153603(Traditional)
ATTN: RENEE MURPHY PHONE NO : 760 4946739
5818 EL CAMINO REAL SE DECISION MADE: 29-APR-16
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBEAT-V and accessories
HITACHI, LTD., HEALTH CARE COMPANY510(k) NO: K153614(Traditional)
ATTN: NAOYA NISHIMURA PHONE NO : 81 3 45643563
4-14-1 SOTOKANDA, CHIYODA-KU SE DECISION MADE: 21-APR-16
TOKYO JP 101-8010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Ray Internal Bone Staple System
FIRST RAY LLC 510(k) NO: K153622(Traditional)
ATTN: Robert Hoy PHONE NO : 614 4486358
124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 08-APR-16
LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K153624(Traditional)
ATTN: Jacson Cambruzzi PHONE NO : 55 41 21694058
AV. JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 15-APR-16
CURTIBA BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Earlens Light Driven Hearing Aid
EARLENS CORPORATION 510(k) NO: K153634(Traditional)
ATTN: Deborah Arthur PHONE NO : 650 3669005
4045-A CAMPBELL AVENUE SE DECISION MADE: 06-APR-16
MENLO PARK CA 94025 510(k) STATEMENT
DEVICE: Bicortical Fixation Screw & Washer Nut System
FIRST RAY LLC 510(k) NO: K153638(Traditional)
ATTN: ROBERT HOY PHONE NO : 614 4486358
124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 19-APR-16
LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneQ-SL s-Clean Implant System
DENTIS CO., LTD. 510(k) NO: K153639(Traditional)
ATTN: SUN CHUL SHIN PHONE NO : 82 53 5822804
99, SEONGSEOSEO-RO, DALSEO-GU SE DECISION MADE: 08-APR-16
DAEGU KR 41718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microcyn Plus Skin and Wound Hydrogel
OCULUS INNOVATIVE SCIENCES 510(k) NO: K153648(Traditional)
ATTN: Brian W. Martin PHONE NO : 707 2830550
1129 N MCDOWELL BLVD SE DECISION MADE: 19-APR-16
PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICOM Viewer
Brainlab AG 510(k) NO: K153653(Traditional)
ATTN: Rainer Birkenbach PHONE NO : 0049 89 9915680
Kapellenstr. 12 SE DECISION MADE: 13-APR-16
Feldkirchen DE 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accuryn Monitoring System
POTRERO MEDICAL, INC. 510(k) NO: K153655(Traditional)
ATTN: DEVYANI NANDURI PHONE NO : 310 3593523
101 MISSISSIPPI ST. SE DECISION MADE: 15-APR-16
SAN FRANCISCO CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Icare ic100
Icare Finland Oy 510(k) NO: K153694(Traditional)
ATTN: Matti Tulikoura PHONE NO : 358 9 87751150
Ayritie 22 SE DECISION MADE: 19-APR-16
Vantaa FI FI-01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chattanooga Revolution Wireless
DJO, LLC 510(k) NO: K153696(Traditional)
ATTN: NATALIA SHIRINA PHONE NO : 760 7345534
1430 DECISION STREET SE DECISION MADE: 14-APR-16
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumenR Tissue Retractor System
LumenR, LLC 510(k) NO: K153698(Traditional)
ATTN: GREGORY PISKUN PHONE NO : 848 4596929
253 MAIN STREET, SUITE 270 SE DECISION MADE: 19-APR-16
MATAWAN NJ 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR 3-Pegs Glenoids
Limacorporate S.p.A. 510(k) NO: K153722(Traditional)
ATTN: Emmanuele Buttazzoni PHONE NO : 39 043 2945511
via Nazionale, 52 SE DECISION MADE: 06-APR-16
Villanova di San Daniele IT 33038510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOPAL plus
HERAEUS MEDICAL GMBH 510(k) NO: K153737(Special)
ATTN: ASTRID MARX PHONE NO : 49 618 1352963
PHILIPP-REIS-STR. 8-13 SE DECISION MADE: 22-APR-16
WEHRHEIM DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TelioCAD Multi
IVOCLAR VIVADENT, INC. 510(k) NO: K153753(Traditional)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 6912260
175 PINEVIEW DRIVE SE DECISION MADE: 12-APR-16
AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Interojo Inc. 510(k) NO: K153766(Traditional)
ATTN: Si-Chul Rho PHONE NO : 82 2 7801225
28 & 25 Sandan-Ro 15beon-Gil SE DECISION MADE: 08-APR-16
Pyongtaek-City KR 459040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crosstella OTW
KANEKA CORPORATION 510(k) NO: K160004(Traditional)
ATTN: TOSHIHIKO MOTOMINE PHONE NO : 81 355 748023
1-12-32, AKASAKA, MINATO-KU SE DECISION MADE: 29-APR-16
TOKYO JP 107-6025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crosperio OTW
KANEKA CORPORATION 510(k) NO: K160013(Traditional)
ATTN: TOSHIHIKO MOTOMINE PHONE NO : 81 3 55748023
1-12-32, AKASAKA, MINATO-KU SE DECISION MADE: 29-APR-16
TOKYO JP 107-6025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U80 Series Upper Arm Electronic Blood Pressure Monitor
SHENZHEN URION TECHNOLOGY CO.,LTD 510(k) NO: K160019(Traditional)
ATTN: AUTUMN LIU PHONE NO : 86 755 29231308
4TH BUILDING, HI-TECH INDUSTRIAL ZSE DECISION MADE: 22-APR-16
SHENZHEN CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian Sterilization Boxes
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K160021(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 HANSEN WAY SE DECISION MADE: 13-APR-16
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Interfixated Interbody System
NuVasive, Incorporated 510(k) NO: K160051(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 Lusk Blvd. SE DECISION MADE: 20-APR-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation
RaySearch Laboratories AB (publ) 510(k) NO: K160093(Traditional)
ATTN: David Hedfors PHONE NO : 46 722 366110
Sveav 44 SE DECISION MADE: 08-APR-16
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Besmed PEEP Valve
BESMED HEALTH BUSINESS CORP. 510(k) NO: K160112(Traditional)
ATTN: ERIC LI PHONE NO : 886 222 903959
NO.5, LANE 116, WU-KONG 2ND RD SE DECISION MADE: 29-APR-16
NEW TAIPEI CITY TW 510(k) STATEMENT
DEVICE: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
SpineVision S.A. 510(k) NO: K160124(Special)
ATTN: Helene Plas PHONE NO : 33 01 53332525
10 rue de la Renaissance, BatimentSE DECISION MADE: 04-APR-16
Antony FR 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cascadia Interbody System
K2M 510(k) NO: K160125(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
751 Miller Drive SE SE DECISION MADE: 22-APR-16
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRO Computed Tomography (CT) X-ray System
Mobius Imaging 510(k) NO: K160126(Traditional)
ATTN: Norma J LeMay PHONE NO : 978 3919644
2 Shaker Road SE DECISION MADE: 19-APR-16
Shirley MA 01464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endopath Electrosurgery Probe Plus II
Ethicon Endo-Surgery, LLC 510(k) NO: K160128(Traditional)
ATTN: Marjorie Medina PHONE NO : 787 6534603
475 Calle C SE DECISION MADE: 28-APR-16
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINERAL OIL
KITAZATO BIOPHARMA CO., LTD. 510(k) NO: K160142(Traditional)
ATTN: Futoshi INOUE PHONE NO : 81 545 662202
81 Nakajima SE DECISION MADE: 21-APR-16
FUJI JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Telescopic PenEvac
I.C. Medical, Inc. 510(k) NO: K160160(Special)
ATTN: Elena S. Buiga PHONE NO : 623 7800700
2340 W. Shangri La Rd. SE DECISION MADE: 05-APR-16
Phoenix AZ 85029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson P6, Voluson P8
GE HEALTHCARE 510(k) NO: K160162(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 6766120
9900 W INNOVATION DR SE DECISION MADE: 26-APR-16
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laparoscope Lens Shield Device
Medeon Biodesign, Inc 510(k) NO: K160172(Special)
ATTN: Greta Chang PHONE NO : 886 2 28816686
7F, 116, HouGang St, SE DECISION MADE: 21-APR-16
Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signia Stapler
Covidien 510(k) NO: K160176(Traditional)
ATTN: Frank Gianelli PHONE NO : 203 4925352
60 Middletown Avenue SE DECISION MADE: 26-APR-16
North Haven CT 06471 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gridlock Ankle Plating System
Trilliant Surgical, LTD 510(k) NO: K160177(Traditional)
ATTN: Jon Olson PHONE NO : 713 3886055
6721 Portwest Dr Ste 160 SE DECISION MADE: 22-APR-16
Houston TX 77024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StarFuse Interphalangeal Pin
Phalanx Innovations 510(k) NO: K160194(Traditional)
ATTN: Daniel Lanois PHONE NO : 888 4043980 101
200 Cobb Pkw N, Bldg 200, Ste 210 SE DECISION MADE: 26-APR-16
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Forma System, Forma Light System
FORMATK SYSTEMS LTD. 510(k) NO: K160195(Traditional)
ATTN: AMIT GOREN PHONE NO : 972 4 8571848
3 HAYOZMA ST. SE DECISION MADE: 15-APR-16
TIRAT HACARMEL IL 3903203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K160202(Traditional)
ATTN: Laura J. Duggan PHONE NO : 302 6317654
500 GBC DRIVE, PO BOX 6101 MS 514 SE DECISION MADE: 27-APR-16
Newark DE 19711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo Cardiovascular Systems Corp510(k) NO: K160206(Traditional)
ATTN: Tierra A Brown PHONE NO : 800 2623304 7021
125 Blue Ball Road SE DECISION MADE: 21-APR-16
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wet Original Personal Lubricant
TRIGG LABORATORIES D/B/A WET INTER510(k) NO: K160211(Traditional)
ATTN: ERICA LORING PHONE NO : 800 2484811
28650 BRAXTON AVENUE SE DECISION MADE: 27-APR-16
VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Spinal Fixation System
INTELLIGENT IMPLANT SYSTEMS, LLC 510(k) NO: K160216(Traditional)
ATTN: MICHAEL NUTT PHONE NO : 704 4241009
3300 INTERNATIONAL AIRPORT DRIVE; SE DECISION MADE: 22-APR-16
CHARLOTTE NC 28208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
COOK INCORPORATED 510(k) NO: K160223(Special)
ATTN: STEVEN LAWRIE PHONE NO : 812 3353575 104518
750 DANIELS WAY SE DECISION MADE: 08-APR-16
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCENTO / HWA Dual/Single laser
BISON MEDICAL CO LTD 510(k) NO: K160227(Traditional)
ATTN: SUN WOO LEE PHONE NO : 82 286 57121
ACE HIGH-END TOWER 6, 234 BEOTKKOTSE DECISION MADE: 22-APR-16
GEUM CHEON GU KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Pump Pack
Abbott Medical Optics Inc. 510(k) NO: K160236(Abbreviated)
ATTN: Priya Viswanathan PHONE NO : 714 2478670
1700 East Saint Andrew Place SE DECISION MADE: 27-APR-16
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: “ULTRA” Telescopes
Olympus Winter & Ibe GmbH 510(k) NO: K160249(Traditional)
ATTN: Katharina Campbell PHONE NO : 49 40 669662997
Kuehnstr. 61 SE DECISION MADE: 21-APR-16
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniPod Insulin Management System
INSULET CORPORATION 510(k) NO: K160252(Traditional)
ATTN: MATTHEW KING PHONE NO : 978 6007427
600 TECHNOLOGY PARK DRIVE SUITE 20SE DECISION MADE: 27-APR-16
BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X5 Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP. 510(k) NO: K160258(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe BSE DECISION MADE: 01-APR-16
Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONACY(TM) I-Hip(TM)
ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K160266(Special)
ATTN: Thomas R. Allen PHONE NO : 574 4536367
4130 CORRIDOR DRIVE SE DECISION MADE: 08-APR-16
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S45 Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP. 510(k) NO: K160283(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe BSE DECISION MADE: 04-APR-16
Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
CAPILLUS, LLC 510(k) NO: K160285(Traditional)
ATTN: PATRICIA SCHNOOR PHONE NO : 786 8881874
1715 NW 82nd AVE SE DECISION MADE: 25-APR-16
MIAMI FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko(TM) Plus R-2 Neuromuscular Stimulator
FIRSTKIND LIMITED 510(k) NO: K160299(Special)
ATTN: NEIL BUCKLEY PHONE NO : 44 014 94572040
HAWK HOUSE PEREGRINE BUSINESS PARKSE DECISION MADE: 08-APR-16
HIGH WYCOMBE GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MotoBand(TM) CP Implant System
CrossRoads Extremity Systems, LLC 510(k) NO: K160300(Traditional)
ATTN: Vernon Hartdegen PHONE NO : 901 2218406
6055 Primacy Pkwy Suite 140 SE DECISION MADE: 22-APR-16
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoBullet Compression Screw
Phalanx Innovations 510(k) NO: K160304(Traditional)
ATTN: Daniel Lanois PHONE NO : 888 4043980 101
200 Cobb Pkw N, Bldg 200, Ste 210 SE DECISION MADE: 29-APR-16
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlasmaFlow
MANAMED, INC 510(k) NO: K160318(Third Party – Traditional)
ATTN: Trevor Theriot PHONE NO : 949 6320355
287 CABRILLO ST. UNIT C SE DECISION MADE: 01-APR-16
Costa Mesa CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Premier
Shandong Weigao Orthopaedic Device510(k) NO: K160320(Traditional)
ATTN: Han Wang PHONE NO : 86 631 5788966
No. 26 Xiangjiang Road, Tourist ReSE DECISION MADE: 01-APR-16
Weihai CN 264203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE Intramedullary Limb Lengthening System
ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K160325(Traditional)
ATTN: Cora Sim PHONE NO : 949 8373600
101 ENTERPRISE, SUITE 100 SE DECISION MADE: 04-APR-16
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K160343(Traditional)
ATTN: JUNE LI PHONE NO : 86 10 67892701
B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 07-APR-16
BEIJING CN 100023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX30N(MX30TQS)
WIDE Corporation 510(k) NO: K160346(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
12 Wongomae-Ro, Giheung-Gu SE DECISION MADE: 14-APR-16
Yongin-Si KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX30N (CX30PQX)
WIDE CORPORATION 510(k) NO: K160348(Traditional)
ATTN: YEOJIN YUN PHONE NO : 82 312 181675
12 WONGOMAE-RO, GIHEUNG-GU SE DECISION MADE: 14-APR-16
YONGIN-SI KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX50N, CX50YQS
WIDE Corporation 510(k) NO: K160351(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
12 Wongomae-Ro, Giheung-Gu SE DECISION MADE: 07-APR-16
Yongin-Si KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX50N(MX50YQS)
WIDE Corporation 510(k) NO: K160353(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
12 Wongomae-Ro, Giheung-Gu SE DECISION MADE: 22-APR-16
Yongin-Si KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX20N(CX20PUX)
WIDE Corporation 510(k) NO: K160355(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
12 Wongomae-Ro, Giheung-Gu SE DECISION MADE: 07-APR-16
Yongin-Si KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrx FLEX RFA Energy Generator
Covidien llc 510(k) NO: K160360(Traditional)
ATTN: Timothy Thomas PHONE NO : 770 6620870 1006
15 Hampshire Street SE DECISION MADE: 05-APR-16
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVO platform
Quanta System SpA 510(k) NO: K160368(Special)
ATTN: FRANCESCO DELL’ANTONIO PHONE NO : 39 0331 376797
Via IV Novembre, 116 SE DECISION MADE: 05-APR-16
Solbiate Olona (VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoSize
Therenva SAS 510(k) NO: K160376(Special)
ATTN: Cemil Goksu PHONE NO : 33 972 522918
4 rue Jean Jaures SE DECISION MADE: 12-APR-16
Rennes FR 35000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Map-it Diagnostic Mapping Catheters
ACCESS POINT TECHNOLOGIES EP, INC.510(k) NO: K160390(Traditional)
ATTN: SEAN CARROLL PHONE NO : 763 4280010
12560 LOCATED AT FLETCHER LANE SUISE DECISION MADE: 11-APR-16
Rogers MN 55374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: spineEOS
ONEFIT MEDICAL 510(k) NO: K160407(Traditional)
ATTN: JULIEN SIMON PHONE NO : 33 381 252427
18 RUE ALAIN SAVARY SE DECISION MADE: 08-APR-16
BESANCON FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anzai Respiratory Gating System
ANZAI MEDICAL CO, LTD. 510(k) NO: K160432(Traditional)
ATTN: NAOYA IWASAKI PHONE NO : 81 3 37792571
3-9-15 NISHI-SHINAGAWA SHINAGAWA-KSE DECISION MADE: 22-APR-16
TOKYO JP 141-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leksell Gamma Knife Icon
Elekta Instrument AB 510(k) NO: K160440(Traditional)
ATTN: Alf Laurell PHONE NO : 011 468 58725400
Kungstensgatan 18 SE DECISION MADE: 20-APR-16
Stockholm SE 10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
BIOFIRE DIAGNOSTICS, LLC 510(k) NO: K160459(Special)
ATTN: Kristen J. Kanack PHONE NO : 801 7366354 330
390 WAKARA WAY SE DECISION MADE: 01-APR-16
SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex iBalance BiCompartmental Arthroplasty System
Arthrex, Inc. 510(k) NO: K160461(Traditional)
ATTN: Courtney Smith PHONE NO : 239 6435553 1720
1370 Creekside Boulevard SE DECISION MADE: 12-APR-16
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opticage(R) Expandable Interbody Fusion Device
INTERVENTIONAL SPINE, INC. 510(k) NO: K160464(Special)
ATTN: JANE METCALF PHONE NO : 949 4720006
13700 ALTON PARKWAY SUITE 160 SE DECISION MADE: 04-APR-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elite SPK, Compasso, Elite SPK Kit
NCS Lab Srl 510(k) NO: K160500(Traditional)
ATTN: Matteo Mantovani PHONE NO : 39 059 669813
Via Pola Esterna 4/12 SE DECISION MADE: 20-APR-16
Carpi MO 41012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIES System
LUMINEX CORPORATION 510(k) NO: K160517(Special)
ATTN: Wendy Ricker PHONE NO : 608 2038936
12212 TECHNOLOGY BLVD. SE DECISION MADE: 12-APR-16
AUSTIN TX 78727 510(k) STATEMENT
DEVICE: White Pearl Preferred Angle Anterior Cervical Plate
OSSEUS FUSION SYSTEMS, LLC 510(k) NO: K160522(Traditional)
ATTN: Robert Pace PHONE NO : 214 3950100
2703 MOCKINGBIRD LANE, SUITE 102 SE DECISION MADE: 26-APR-16
Dallas TX 75235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC-Subtalar(TM) II
MERETE MEDICAL GMBH 510(k) NO: K160548(Traditional)
ATTN: PAUL MUNCH PHONE NO : 49 307 79980181
ALT-LANKWITZ SE DECISION MADE: 29-APR-16
BERLIN DE 12247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
RAYENCE CO., LTD 510(k) NO: K160579(Special)
ATTN: Kevin Kim PHONE NO : 82 318 0156459
14, SAMSUNG 1-RO, 1-GIL SE DECISION MADE: 08-APR-16
Hwaseong-si KR 445-170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NormaTec Pulse and NormaTec Pulse Pro
NORMATEC INDUSTRIES, LP 510(k) NO: K160608(Third Party – Traditional)
ATTN: Peter Novello PHONE NO : 617 9283400
44 GLEN AVE SE DECISION MADE: 13-APR-16
Newton MA 02459 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: G3(TM) Active Plate(R) Small Fragment System
GENESIS FRACTURE CARE, INC. 510(k) NO: K160633(Traditional)
ATTN: Michael Bottlang PHONE NO : 503 5284048
13568 SE 97th Ave. Suite 202 SE DECISION MADE: 22-APR-16
Clackamas OR 97015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FlowSmart Set, MiniMed Pro-Set
BECTON, DICKINSON AND COMPANY 510(k) NO: K160651(Special)
ATTN: Matthew Trachtenberg PHONE NO : 201 8476337
1 BECTON DRIVE SE DECISION MADE: 07-APR-16
Franklin Lakes NJ 07666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
ASAHI INTECC CO., LTD. 510(k) NO: K160659(Special)
ATTN: CARROLL COUNCILMAN PHONE NO : 949 7562852
2055 RED HILL AVENUE, SUITE 210 SE DECISION MADE: 07-APR-16
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fujifilm Sonosite Vevo MD Imaging System
FUJIFILM SONOSITE, INC. 510(k) NO: K160674(Third Party – Traditional)
ATTN: SCOTT PAULSON PHONE NO : 425 9516926
21919 30TH DRIVE SE SE DECISION MADE: 19-APR-16
BOTHELL WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Reveal LINQ
MEDTRONIC, INC. 510(k) NO: K160689(Special)
ATTN: Eric Kalmes PHONE NO : 763 5262809
8200 CORAL SEA STREET NE SE DECISION MADE: 22-APR-16
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neptune E-SEP Smoke Evacuation Pencil
STRYKER CORPORATION 510(k) NO: K160693(Special)
ATTN: MAIREAD TWOMEY PHONE NO : 353 21 4532988
4100 E. MILHAM AVENUE SE DECISION MADE: 13-APR-16
KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Nanostim Introducer Kit
St Jude Medical, Inc 510(k) NO: K160716(Special)
ATTN: Brittany Cunningham PHONE NO : 408 5226591
645 Almanor Avenue SE DECISION MADE: 14-APR-16
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonoSite SII Ultrasound System
FUJIFILM SonoSite, Inc. 510(k) NO: K160734(Third Party – Traditional)
ATTN: Patricia Liau PHONE NO : 425 9516870
21919 30th Drive SE SE DECISION MADE: 05-APR-16
Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CRIT-LINE III Blood Chamber II
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K160749(Special)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 WINTER STREET SE DECISION MADE: 15-APR-16
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS OCT Spinal System
MEDICREA INTERNATIONAL S.A. 510(k) NO: K160756(Traditional)
ATTN: David Ryan PHONE NO : 0033 4 72018787
14 Porte du Grand Lyon SE DECISION MADE: 26-APR-16
NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIOScan (RPS500)
RAY CO., Ltd 510(k) NO: K160788(Traditional)
ATTN: Changhwan Lee PHONE NO : 82 31 6051000
332-7, Samsung 1-ro SE DECISION MADE: 15-APR-16
Hwaseong-si KR 445-330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acclarix LX8 Diagnostic Ultrasound System
Edan Instruments Inc 510(k) NO: K160790(Third Party – Traditional)
ATTN: Queena Chen PHONE NO : 86 755 26858736
3/F-B, Nanshan Medical Equipments SE DECISION MADE: 04-APR-16
Shenzhen CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
THE PROMETHEUS GROUP 510(k) NO: K160792(Traditional)
ATTN: Joshua Bird PHONE NO : 603 7490733
1 WASHINGTON STREET SUITE 303 SE DECISION MADE: 15-APR-16
DOVER NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
PHILIPS ULTRASOUND, INC. 510(k) NO: K160807(Third Party – Traditional)
ATTN: PENG CUI PHONE NO : 978 6597966
3000 MINUTEMAN ROAD SE DECISION MADE: 06-APR-16
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Sydney IVF Sperm Cryopreservation Buffer
WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K160814(Special)
ATTN: GORDANA POZVEK PHONE NO : 61 7 38411188
95 BRANDL STREET SE DECISION MADE: 22-APR-16
EIGHT MILES PLAINS AU 4113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantheris Catheter
AVINGER, INC. 510(k) NO: K160827(Special)
ATTN: Golnaz Moeini PHONE NO : 650 2417900
400 CHESAPEAKE DRIVE SE DECISION MADE: 21-APR-16
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra Smart Coil
PENUMBRA, INC. 510(k) NO: K160832(Special)
ATTN: Charles DeNault PHONE NO : 510 7483302
ONE PENUMBRA PLACE SE DECISION MADE: 20-APR-16
ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CompactCath Intermittent Urinary Catheter
COMPACTCATH INC. 510(k) NO: K160858(Special)
ATTN: Naama Stauber Breckler PHONE NO : 408 8939776
887 FEDERATION WAY SE DECISION MADE: 26-APR-16
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Denali Filter System – Femoral Delivery Kit, Denali Filter System – Jugular/Subclavian Delivery Kit
C.R. BARD, INC. 510(k) NO: K160866(Special)
ATTN: LAURIE SANG PHONE NO : 480 3506069
1625 W. THIRD ST. SE DECISION MADE: 29-APR-16
TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie’s Repair Graft
COOK BIOTECH INCORPORATED 510(k) NO: K160869(Special)
ATTN: Perry W. Guinn PHONE NO : 765 4973355
1425 INNOVATION PLACE SE DECISION MADE: 29-APR-16
WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sterEOS Workstation
EOS IMAGING, INC. 510(k) NO: K160914(Special)
ATTN: MATHIAS BREUIL PHONE NO : 33 1 55256060
10 RUE MERCOEUR