510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2017
DEVICE: Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
TIANJIN EMPECS MEDICAL DEVICE CO.,510(k) NO: K152534(Special)
ATTN: CHAE CHUNG LYUEL PHONE NO : 82 70 71240474
NO.35 AND 37, YINGCHENG STREET SE DECISION MADE: 21-MAR-17
HANGU CN 300480 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dextramer CMV Kit
Immudex Aps 510(k) NO: K153538(Traditional)
ATTN: Liselotte Brix PHONE NO : 45 4 0910121
Fruebjergvej 3 SE DECISION MADE: 02-MAR-17
Copenhagen DK 2100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Consult Station TS
H4D SAS 510(k) NO: K153600(Traditional)
ATTN: MARTA RIVAS PHONE NO : 33 170 814949
92 AVENUE KLEBER SE DECISION MADE: 17-MAR-17
PARIS FR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edi Catheter ENFit
MAQUET CRITICAL CARE AB 510(k) NO: K153688(Traditional)
ATTN: MIRVA BOOTHE PHONE NO : 46 10 3357300
RONTGENVAGEN 2 SE DECISION MADE: 02-MAR-17
SOLNA SE SE-171 54 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RenovoCath
RenovoRx, Inc. 510(k) NO: K160067(Traditional)
ATTN: Kamran Najmabadi PHONE NO : 650 2844433
4546 El Camino Real, Suite 282 SE DECISION MADE: 07-MAR-17
Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luggie Chair
FREERIDER CORPORATION 510(k) NO: K160139(Traditional)
ATTN: Arthur Wang PHONE NO : 886 762 23093
NO.22 BENGONG 5TH ROAD SE DECISION MADE: 20-MAR-17
Kang-Shan Dist TW 820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Barostat Bag (RBB) Pump and Catheter
MUI SCIENTIFIC 510(k) NO: K160287(Traditional)
ATTN: TAMMY MUI PHONE NO : 905 8905525
145 TRADERS BLVD. EAST #33-34 SE DECISION MADE: 14-MAR-17
MISSISSAUGA CA L4Z 3L3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glass Ionomer Cement
SHANDONG HUGE DENTAL MATERIAL CORP510(k) NO: K160345(Traditional)
ATTN: Steven Song PHONE NO : 086 633 2277285
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 03-MAR-17
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K3PRO Konus Additional Abutments and Implants
ARGON MED. PRODUCTIONS VERTRIEBS G510(k) NO: K160581(Traditional)
ATTN: RICHARD DONACA PHONE NO : 011 4967 2130960
MAINZER STR 346 SE DECISION MADE: 24-MAR-17
BINGEN AM RHEIN DE 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solitaire Platinum Revascularization Device, 6x40 mm
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K160641(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 2975489
9775 Toledo Way SE DECISION MADE: 08-MAR-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
MAQUET CRITICAL CARE AB 510(k) NO: K160665(Abbreviated)
ATTN: CARINA LUNDBERG PHONE NO : 011 461 03357300
RONTGENVAGEN 2 SE DECISION MADE: 29-MAR-17
SOLNA SE SE-171 54 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vado Steerable Sheath
KALILA MEDICAL, INC. 510(k) NO: K160721(Traditional)
ATTN: Carrie Neuberger PHONE NO : 408 6372150
745 CAMDEN AVE, SUITE A SE DECISION MADE: 07-MAR-17
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Interstitial Needles
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K160815(Traditional)
ATTN: PETER J. CORONADO PHONE NO : 650 4246320
911 HANSEN WAY SE DECISION MADE: 10-MAR-17
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RnD TE and RnD SE
Apex Dental Materials, Inc 510(k) NO: K161077(Traditional)
ATTN: Scott Lamerand PHONE NO : 847 7191133
330 Telser Road SE DECISION MADE: 17-MAR-17
Lake Zurich IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
PENTAFERTE ITALIA S.R.L. 510(k) NO: K161141(Traditional)
ATTN: ROSA DI GIOIA PHONE NO : 39 086 1560201
LOC. NOCELLA SP 262 SE DECISION MADE: 22-MAR-17
CAMPLI IT I-64012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OC-FLEX Flexible IntraOral Cannula
Venture Therapeutics, Inc. 510(k) NO: K161250(Traditional)
ATTN: Marilyn A. Friedly PHONE NO : 614 4303300
6525 Doubletree Avenue SE DECISION MADE: 17-MAR-17
Columbus OH 43229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiPulse HoPLUS
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K161257(Special)
ATTN: ANTJE KATZER PHONE NO : 49 364 17700309
BRUESSELER STR. 10 SE DECISION MADE: 31-MAR-17
JENA DE 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoPur Filter
Nephros Inc. 510(k) NO: K161304(Traditional)
ATTN: Hollie Johnson PHONE NO : 1 201 3435202
41 Grand Ave SE DECISION MADE: 02-MAR-17
River Edge NJ 07661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
TEDAN SURGICAL INNOVATIONS LLC 510(k) NO: K161318(Traditional)
ATTN: John Willis PHONE NO : 713 7260886
12615 W. AIRPORT BLVD, SUITE 200 SE DECISION MADE: 20-MAR-17
SUGAR LAND TX 77478 510(k) STATEMENT
DEVICE: Multi-unit Abutment Plus
NOBEL BIOCARE AB 510(k) NO: K161416(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 16-MAR-17
GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerfectSmooth
SHEN ZHEN COSBEAUTY CO.,LTD. 510(k) NO: K161428(Traditional)
ATTN: Nicole Hu PHONE NO : 86 755 86271293 8806
UNIT A- 3F, QIAO DE INDUSTRIAL PARSE DECISION MADE: 23-MAR-17
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myoject Luer Lock Needle Electrode
Natus Manufacturing Limited 510(k) NO: K161430(Traditional)
ATTN: Michael Galvin PHONE NO : 353 091 630043
IDA Business Park SE DECISION MADE: 02-MAR-17
Gort IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plum 360™ Infusion System with MedNet/ Smart Card Plug ‘n’ Play Module
Hospira, Inc 510(k) NO: K161469(Traditional)
ATTN: Keith Dunn PHONE NO : 224 2124898
275 North Field Drive SE DECISION MADE: 28-MAR-17
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bluetooth blood pressure monitor
SHENZHEN KINGYIELD TECHNOLOGY CO.,510(k) NO: K161530(Special)
ATTN: Dacheng Gong PHONE NO : 86 755 27371997
BLDG C, FUHAI INDUSTRIAL ZONE, FUHSE DECISION MADE: 31-MAR-17
SHENZHEN CN 518000 510(k) STATEMENT
DEVICE: Transem and EchoGen Embryo Transfer Catheters
ORIGIO A/S 510(k) NO: K161547(Traditional)
ATTN: TOVE KJAER PHONE NO : 45 46 790202
KNARDRUPVEJ 2 SE DECISION MADE: 09-MAR-17
MAALOEV DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFLATOR 40, ENDOFLATOR 50
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K161554(Traditional)
ATTN: SUSIE S. CHEN PHONE NO : 424 2188201
2151 E. GRAND AVENUE SE DECISION MADE: 02-MAR-17
EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelZygoma 0°
Nobel Biocare AB 510(k) NO: K161598(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
Box 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 14-MAR-17
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXLON, REXSIL
SM ENG CO., LTD 510(k) NO: K161633(Traditional)
ATTN: SOON-GU LEE PHONE NO : 82 51 3058016
46, NAKDONG-DAERO 1302BEON-GIL SE DECISION MADE: 02-MAR-17
SASANG-GU KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIStem-H Proximal Coating
MEDACTA INTERNATIONAL SA 510(k) NO: K161635(Traditional)
ATTN: STEFANO BAJ PHONE NO : 41 91 6966060
STRADA REGINA SE DECISION MADE: 31-MAR-17
CASTEL SAN PIETRO CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire Infusion Pump
Q Core Medical Ltd. 510(k) NO: K161667(Traditional)
ATTN: Shimon Vaknin PHONE NO : 972 73 2388803
29 Yad Haruzim St. SE DECISION MADE: 27-MAR-17
Netanya IL 4250529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICON Spinal Spreading Systems
MEDICON EG 510(k) NO: K161680(Traditional)
ATTN: Joachim Schmid PHONE NO : 49 7462 20090
GANSACKER 15 SE DECISION MADE: 24-MAR-17
TUTTLINGEN DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nipro SafeTouch IV Catheter
NIPRO MEDICAL CORPORATION 510(k) NO: K161681(Traditional)
ATTN: JESSICA OSWALD-MCLEOD PHONE NO : 305 5997174
3150 NW 107TH AVE. SE DECISION MADE: 08-MAR-17
MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Direct LDL Cholesterol (LDL)
RANDOX LABORATORIES LIMITED 510(k) NO: K161691(Traditional)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 028 94422413 2275
55 DIAMOND ROAD CRUMLIN SE DECISION MADE: 20-MAR-17
CRUMLIN GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U2 Total Knee System E-XPE products
UNITED ORTHOPEDIC CORPORATION 510(k) NO: K161705(Traditional)
ATTN: KAREN HO PHONE NO : 886 357 73351 2212
NO 57, PARK AVE 2 SCIENCE PARK SE DECISION MADE: 16-MAR-17
HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleveland Multiport Ventricular Catheter Set
Parker Hannifin Corp. 510(k) NO: K161731(Traditional)
ATTN: George Austria PHONE NO : 805 6582984
3007 Bunsen Ave. SE DECISION MADE: 27-MAR-17
Ventura CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Sorin Group Italia S.r.l 510(k) NO: K161733(Traditional)
ATTN: Luigi Vecchi PHONE NO : 011 39 053529811
86, Via Statale 12 Nord SE DECISION MADE: 08-MAR-17
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
MYCO MEDICAL 510(k) NO: K161737(Abbreviated)
ATTN: Sanjiv Kumar PHONE NO : 919 4602535
158 TOWERVIEW COURT SE DECISION MADE: 02-MAR-17
CARY NC 27513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THD ANOPRESS
THD SPA 510(k) NO: K161785(Traditional)
ATTN: GIUSEPPINA GIANNINI PHONE NO : 39 0522 634311
VIA DELL'INDUSTRIA 1 SE DECISION MADE: 14-MAR-17
CORREGGIO IT 42015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freedom Syringe
Procedure Products, Inc. 510(k) NO: K161812(Abbreviated)
ATTN: Doug Rowley PHONE NO : 360 6931832
1801 W. 4th Plain Blvd. SE DECISION MADE: 27-MAR-17
Vancouver WA 98660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
bioMerieux, Inc. 510(k) NO: K161816(Traditional)
ATTN: Jolyn Tenllado PHONE NO : 314 7318386
595 Anglum Rd. SE DECISION MADE: 28-MAR-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iovera system
Myoscience, Inc 510(k) NO: K161835(Traditional)
ATTN: Tracey Henry PHONE NO : 510 9331500
46400 Fremont blvd SE DECISION MADE: 24-MAR-17
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
Waldemar Link GmbH & Co. KG 510(k) NO: K161840(Traditional)
ATTN: Lorenz Runge PHONE NO : 49 40 53995305
Oststrabe 4-10 SE DECISION MADE: 16-MAR-17
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSage Rx (iSage Rx Basal Insulin Titration)
iSag Rx, Inc. 510(k) NO: K161865(Traditional)
ATTN: RYAN SYSKO PHONE NO : 302 9830001
206 ALAPOCAS DR SE DECISION MADE: 07-MAR-17
WILMINGTON DE 19803 510(k) STATEMENT
DEVICE: NIVR58-T kit
Barco N.V. 510(k) NO: K161880(Special)
ATTN: Lieven De Wandel PHONE NO : 32 56 233459
President Kennedypark 35 SE DECISION MADE: 14-MAR-17
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Slimming Treatment Device
BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K161892(Traditional)
ATTN: Li Yanzhe PHONE NO : 86 10 56370050 607
72 bldg., Golden bridge S&T indus.SE DECISION MADE: 02-MAR-17
Beijing CN 101102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
BEIJING FERT TECHNOLOGY CO., LTD 510(k) NO: K161898(Traditional)
ATTN: MENG ZHANG PHONE NO : 86 108 3849578
NO.9, ZHANGGUOZHUANG VILLAGE, CHANSE DECISION MADE: 08-MAR-17
Beijing CN 100072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SREE MRI Transport Incubator
ADVANCED IMAGING RESEARCH DBA SREE510(k) NO: K161918(Traditional)
ATTN: RAVI SRINIVASAN PHONE NO : 216 4261461
PO BOX 603220 SE DECISION MADE: 03-MAR-17
CLEVELAND OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
Dipped Products (Thailand) Limited510(k) NO: K161929(Traditional)
ATTN: Nilaksha Pushpakumara PHONE NO : 00 66 74302100
82/2 MOO 9, Tumbon Rattapum SE DECISION MADE: 29-MAR-17
Amphur Khun Nieng TH 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics 510(k) NO: K161954(Traditional)
ATTN: Justin DiValentino PHONE NO : 914 5242280
511 Benedict Avenue SE DECISION MADE: 09-MAR-17
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit enteral syringe
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K161979(Traditional)
ATTN: JUN LU PHONE NO : 86 510 86205183
NO.2, TAIFU ROAD, HUASHI TOWN SE DECISION MADE: 22-MAR-17
JIANGYIN CN 214421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curasite
IZUN PHARMACEUTICALS 510(k) NO: K161991(Traditional)
ATTN: JACK TALLEY PHONE NO : 858 3351300
ONE ROCKEFELLER PLAZA, 11TH FLOOR SE DECISION MADE: 03-MAR-17
NEW YORK NY 10020 510(k) STATEMENT
DEVICE: CardioDay V2.5
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K162023(Traditional)
ATTN: BERT SCHADOW PHONE NO : 49 332 8394270
ODERSTR. 77 SE DECISION MADE: 24-MAR-17
TELTOW DE 14513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
MicroPort Orthopedics, Inc. 510(k) NO: K162026(Traditional)
ATTN: Byron Ledbetter PHONE NO : 901 2905943
5677 Airline Road SE DECISION MADE: 01-MAR-17
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIUM - SHELTA Prosthetic Components
SWEDEN & MARTINA S.p.A. 510(k) NO: K162028(Traditional)
ATTN: ALESSIA PEZZATO PHONE NO : 39 049 9124300
via veneto, 10 SE DECISION MADE: 24-MAR-17
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: SALVATION External Fixation System
WRIGHT MEDICAL 510(k) NO: K162033(Traditional)
ATTN: LESLIE FITCH PHONE NO : 901 8674120
1023 CHERRY ROAD SE DECISION MADE: 06-MAR-17
MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Sphere
Medacta International SA 510(k) NO: K162035(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 06-MAR-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse with VEMP
INTERACOUSTICS A/S 510(k) NO: K162037(Traditional)
ATTN: Erik Nielsen PHONE NO : 45 637 13555
AUDIOMETER ALLE 1 SE DECISION MADE: 23-MAR-17
Middelfart DK 5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentca Denture Base II
DENTCA, Inc. 510(k) NO: K162044(Traditional)
ATTN: Jason Lee PHONE NO : 424 5588726
357 Van Ness Way #250 SE DECISION MADE: 03-MAR-17
Torrance CA 90501 510(k) STATEMENT
DEVICE: JOINIX CANNULAR SYSTEM
AJU Pharm Co.,Ltd. 510(k) NO: K162070(Traditional)
ATTN: Kim Jung Gil PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 16-MAR-17
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
DePuy Synthes 510(k) NO: K162124(Traditional)
ATTN: CHRISTOPHER J. MEDBERRY PHONE NO : 610 7196806
1301 GOSHEN PARKWAY SE DECISION MADE: 29-MAR-17
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caphosol Artifical Saliva Tablets
EUSA Pharma (UK) Limited 510(k) NO: K162167(Traditional)
ATTN: Paul Davisson PHONE NO : 44 1732 832317
Breakspear Park, Breakspear Way SE DECISION MADE: 31-MAR-17
Hemel Hempstead GB HP2-4TZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
BRIGHTWAY HOLDINGS SDN BHD 510(k) NO: K162186(Traditional)
ATTN: G. BASKARAN PHONE NO : 603 33431007
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 31-MAR-17
KLANG MY 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cascade IOMAX Intraoperative Monitor
CADWELL INDUSTRIES, INC. 510(k) NO: K162199(Traditional)
ATTN: MELISSA KIRKUP PHONE NO : 509 7356481
909 NORTH KELLOGG STREET SE DECISION MADE: 02-MAR-17
KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOYON
Oculus Innovative Sciences 510(k) NO: K162217(Traditional)
ATTN: Brian W. Martin PHONE NO : 707 2830550
1129 N. McDowell Boulevard SE DECISION MADE: 23-MAR-17
Petaluma CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUVENA VAGINAL MOISTURIZER & LUBRICANT
LACLEDE, INC. 510(k) NO: K162235(Traditional)
ATTN: MICHAEL PELLICO PHONE NO : 310 6054280
2103 E. UNIVERSITY DR. SE DECISION MADE: 24-MAR-17
RANCHO DOMINGUEZ CA 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCI Total Vitamin D Total Assay, LOCI VITD CAL
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K162298(Traditional)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781 8264551
500 GBC DRIVE P.O. BOX 6101 SE DECISION MADE: 16-MAR-17
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noris Medical MBI-2mm Dental Implant System
Noris Medical Ltd 510(k) NO: K162308(Traditional)
ATTN: Simha Sibony PHONE NO : 972 73 7964477
8 Hataasia SE DECISION MADE: 17-MAR-17
Nesher IL 3688808 510(k) STATEMENT
DEVICE: StealthStation S8 System Platforms and StealthStation Cranial Software
MEDTRONIC NAVIGATION, INC. 510(k) NO: K162309(Traditional)
ATTN: Tia Fushimi-Bain PHONE NO : 720 8903200
826 COAL CREEK CIRCLE SE DECISION MADE: 31-MAR-17
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann PrefGel
INSTITUT STRAUMANN AG 510(k) NO: K162311(Traditional)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 41 61 9651260
PETER MERIAN WEG 12 SE DECISION MADE: 07-MAR-17
BASEL CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Next Generation NVM5 System
NUVASIVE INCORPORATED 510(k) NO: K162313(Traditional)
ATTN: MARY ADAMS PHONE NO : 909 9915235
7475 LUSK BLVD. SE DECISION MADE: 16-MAR-17
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
Exactech Inc 510(k) NO: K162325(Special)
ATTN: Zach Sharrah PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 06-MAR-17
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stellaris Elite Vision Enhancement System
Bausch + Lomb 510(k) NO: K162342(Traditional)
ATTN: Ken Nehmer PHONE NO : 636 2263017
3365 Tree Ct. Industrial Blvd. SE DECISION MADE: 24-MAR-17
St. Louis MO 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesair Cystoscopic Sheath
Solace Therapeutics 510(k) NO: K162356(Special)
ATTN: William Gruber PHONE NO : 508 2831200
135 Newbury St SE DECISION MADE: 02-MAR-17
Framingham MA 01701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intellijoint HIP Generation 2A System
INTELLIJOINT SURGICAL INC. 510(k) NO: K162364(Traditional)
ATTN: BRANDON GINGRICH PHONE NO : 1 519 3423178
60 BATHURST DR., UNIT 6 SE DECISION MADE: 02-MAR-17
WATERLOO CA N2V 2A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell Sierra Summit, Cadwell Sierra Ascent
CADWELL INDUSTRIES, INC. 510(k) NO: K162383(Traditional)
ATTN: CHRISTOPHER BOLKAN PHONE NO : 509 7356481
909 NORTH KELLOGG STREET SE DECISION MADE: 01-MAR-17
KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRC-77tHR
Capintec, Inc. 510(k) NO: K162394(Traditional)
ATTN: Mary Anne Yusko PHONE NO : 201 8259500
7 Vreeland Road SE DECISION MADE: 08-MAR-17
Florham Park NJ 07932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K162405(Traditional)
ATTN: CHAN YEW MEN PHONE NO : 605 8472777
LOT 821, JALAN MATANG SE DECISION MADE: 28-MAR-17
MATANG MY 84750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIPCAM 1S 3D System
KARL STORZ Endoscopy America, Inc 510(k) NO: K162410(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E.Grand Avenue SE DECISION MADE: 02-MAR-17
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hoggan Scientific® microFET2™
Hoggan Scientific, LLC 510(k) NO: K162412(Traditional)
ATTN: Spencer Walker PHONE NO : 801 5815080
3653 West 1987 South Bld. # 7 SE DECISION MADE: 09-MAR-17
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
STERIS Corporation 510(k) NO: K162413(Traditional)
ATTN: Bill Brodbeck PHONE NO : 440 3542600
5960 Heisley Rd SE DECISION MADE: 31-MAR-17
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectra 9Plus
Uzinmedicare Company 510(k) NO: K162415(Traditional)
ATTN: Nathan Ahn PHONE NO : 82 31 7395271
Room 105, Joongang Induspia V, SagSE DECISION MADE: 15-MAR-17
Seoul KR 13202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZipE Knotless Tissue Repair and Attachment Devices
ZIPTEK, LLC 510(k) NO: K162429(Traditional)
ATTN: William F. Bennett PHONE NO : 941 9535509
1250 S TAMIAMI TRL STE 303 SE DECISION MADE: 13-MAR-17
Sarasota FL 34239-2221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hach CM130 Chlorine Monitoring System
HACH COMPANY 510(k) NO: K162471(Traditional)
ATTN: Jeff Ryberg PHONE NO : 714 5167659
100 DAYTON AVENUE SE DECISION MADE: 30-MAR-17
AMES IA 50010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
Cardiac Insight, Inc. 510(k) NO: K162503(Traditional)
ATTN: Brad Harlow PHONE NO : 206 5962061
3230 Carillon Point SE DECISION MADE: 24-MAR-17
Kirkland WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhotoFix Decellularized Bovine Pericardium
CryoLife, Inc. 510(k) NO: K162506(Traditional)
ATTN: Heather Emerick PHONE NO : 770 4193355 4502
1655 Roberts Blvd., N.W. SE DECISION MADE: 09-MAR-17
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Non-contact Thermometer, Model ACT8100
EASYWELL BIOMEDICALS, INC. 510(k) NO: K162509(Traditional)
ATTN: Arthur Chen PHONE NO : 886 36669596
SUITE 2, 2F, NO.9, JHANYE 1ST RD, SE DECISION MADE: 10-MAR-17
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraCath Continuous Nerve block Catheter
TELEFLEX MEDICAL , INC. 510(k) NO: K162522(Traditional)
ATTN: James A. Cochie PHONE NO : 919 4332703
3015 Carrington Mill Blvd SE DECISION MADE: 17-MAR-17
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUR CX Detachable 18 Peripheral Coil System
MicroVention, Inc 510(k) NO: K162524(Traditional)
ATTN: Laraine Pangelina PHONE NO : 714 2478150
1311 Valencia Avenue SE DECISION MADE: 03-MAR-17
Tustin CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K162529(Traditional)
ATTN: Manmohan Singh PHONE NO : 91 01762 662626
Bhankharpur, Mubarakpur Road SE DECISION MADE: 03-MAR-17
Derabassi, Distt Mohali IN 140507510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multichem IA Plus
TECHNO-PATH MANUFACTURING 510(k) NO: K162530(Abbreviated)
ATTN: BERND HASS PHONE NO : 353 61 525700
BALLINA SE DECISION MADE: 31-MAR-17
CO. TIPPERARY IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTFUSION LED SYSTEM
VITAGE LED LTD 510(k) NO: K162556(Traditional)
ATTN: SUE D'ARCY PHONE NO : 44 0 3330142434
THE PAVILLION, JOSSELIN ROAD SE DECISION MADE: 24-MAR-17
BASILDON GB SS131QB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Move Forward 3D Motion Simulation Service
BIOMET INC. 510(k) NO: K162559(Traditional)
ATTN: PAUL HARDY PHONE NO : 574 3726799
56 EAST BELL DRIVE SE DECISION MADE: 31-MAR-17
WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
BCG MEDICAL, LLC 510(k) NO: K162562(Traditional)
ATTN: LISA GIAP PHONE NO : 858 3491331
6715 RANCHO TOYON PLACE SE DECISION MADE: 17-MAR-17
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-LINKPC System
ZAVATION, LLC 510(k) NO: K162575(Traditional)
ATTN: FRANKIE CUMMINS PHONE NO : 601 9191119
220 LAKELAND PARKWAY SE DECISION MADE: 03-MAR-17
FLOWOOD MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardian Angel GA1000 Digital Vital Sign Monitoring System
TAIWAN AULISA MEDICAL DEVICES TECH510(k) NO: K162580(Traditional)
ATTN: ALAN TANG PHONE NO : 886 2 26557297 18
RM. 1052, BLDG.H, 10F., NO.3-2, YUSE DECISION MADE: 03-MAR-17
TAIPEI CITY TW 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adscope 658 Electronic Stethoscope
AMERICAN DIAGNOSTIC CORP. 510(k) NO: K162589(Traditional)
ATTN: Michael Falco PHONE NO : 631 2739600
55 COMMERCE DR. SE DECISION MADE: 10-MAR-17
HAUPPAUGE NY 11788 510(k) STATEMENT
DEVICE: Mould Applicator Set
Varian Medical Systems, Inc 510(k) NO: K162615(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246230
911 Hansen Way SE DECISION MADE: 24-MAR-17
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
TOP QUALITY GLOVE SDN. BHD 510(k) NO: K162626(Traditional)
ATTN: HUE KON FAH PHONE NO : 603 33923375
LOT 4961, JALAN TERATAI, BATU 6, OSE DECISION MADE: 31-MAR-17
KLANG MY 41050 510(k) STATEMENT
DEVICE: EnsoSleep
EnsoData, Inc. 510(k) NO: K162627(Traditional)
ATTN: Chris Fernandez PHONE NO : 630 8625738
111 N. Fairchild Street, Suite 240SE DECISION MADE: 31-MAR-17
Madison WI 53703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
HARTALEGA NGC SDN. BHD. 510(k) NO: K162646(Traditional)
ATTN: KUAN MUN LEONG PHONE NO : 603 62771733
KAWASAN PERINDUSTRIAN TANJUNG, SE DECISION MADE: 03-MAR-17
SEPANG MY 43900 510(k) STATEMENT
DEVICE: mollosil plus
DETAX GmbH & Co.KG 510(k) NO: K162654(Traditional)
ATTN: Antje Reeps PHONE NO : 49 7243 5100
Carl-Zeiss-Str. 4 SE DECISION MADE: 13-MAR-17
Ettlingen DE 76275 510(k) STATEMENT
DEVICE: VertebraLINK Fusion Platform
FACETLINK DBA LINKSPINE 510(k) NO: K162693(Traditional)
ATTN: MASSIMO CALAFIORE PHONE NO : 973 6274171
101 ROUNDHILL DRIVE SE DECISION MADE: 29-MAR-17
ROCKAWAY NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Assert Self-Contained Biological Indicator
STERIS CORPORATION 510(k) NO: K162701(Traditional)
ATTN: ANTHONY PIOTRKOWSKI PHONE NO : 440 3927437
5960 HEISLEY RD SE DECISION MADE: 24-MAR-17
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse Implant System® - iFuse-3D implant
SI-BONE, INC. 510(k) NO: K162733(Traditional)
ATTN: ROXANNE DUBOIS PHONE NO : 408 2070700 2236
3055 OLIN AVE, SUITE 2200 SE DECISION MADE: 10-MAR-17
SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
BECKMAN COULTER, INC. 510(k) NO: K162740(Traditional)
ATTN: SHANNON POPSON PHONE NO : 916 3743330
1584 ENTERPRISE BLVD SE DECISION MADE: 21-MAR-17
WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ontex and other proprietary names
ONTEX BVBA 510(k) NO: K162746(Traditional)
ATTN: Henri Lesage PHONE NO : 32 52 454611
5 Genthof SE DECISION MADE: 03-MAR-17
Buggenhout Oost-Vlaanderen BE 925510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
STERIS Corporation 510(k) NO: K162758(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3542600
5960 Heisley Rd SE DECISION MADE: 21-MAR-17
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silk'n HST
Home Skinovations Ltd. 510(k) NO: K162784(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 25-MAR-17
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foresight Intracardiac Echocardiology (ICE) System
Conavi Medical Inc. 510(k) NO: K162789(Traditional)
ATTN: Sam Mostafavi PHONE NO : 416 4830100
293 Lesmill Road SE DECISION MADE: 28-MAR-17
Toronto CA M3B 2V1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHMIA HDx Mapping System
Boston Scientific Corporation 510(k) NO: K162793(Traditional)
ATTN: Regina Holmes PHONE NO : 617 2183873
125 Cambridgepark Drive Suite 600 SE DECISION MADE: 10-MAR-17
Cambridge MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q2 Low Pressure Power Injection Extension Set
QUEST MEDICAL, INC. 510(k) NO: K162804(Traditional)
ATTN: Amy Clendening-Wheeler PHONE NO : 972 3326338
ONE ALLENTOWN PARKWAY SE DECISION MADE: 08-MAR-17
ALLEN TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Conditional CGA 870
Essex Industries, Inc. 510(k) NO: K162811(Traditional)
ATTN: Russ Jacobsmeyer PHONE NO : 314 3388723
7700 Gravois SE DECISION MADE: 02-MAR-17
St. Louis MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC3 Series IABP System
ARROW INTERNATIONAL, INC. 510(k) NO: K162820(Traditional)
ATTN: Alifiya Jagmag PHONE NO : 978 2505100
16 ELIZABETH DR SE DECISION MADE: 31-MAR-17
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Surgical System
FUJIFILM New Development U.S.A., I510(k) NO: K162836(Traditional)
ATTN: Stephen Mariano PHONE NO : 781 8602463
318 Bear Hill Road SE DECISION MADE: 13-MAR-17
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GuideMia Ortho+
GUIDEMIA TECHNOLOGIES, LLC 510(k) NO: K162850(Traditional)
ATTN: FEI GAO PHONE NO : 714 3912739
5030 KATELLA AVE., STE 209 SE DECISION MADE: 24-MAR-17
LOS ALAMITOS CA 90720 510(k) STATEMENT
DEVICE: Exam Vue PACS
JPI Healthcare Solutions, Inc 510(k) NO: K162868(Traditional)
ATTN: Jang Won Lee PHONE NO : 82 31 4913453 100
Woolim E-Biz Center #608, 170-5 SE DECISION MADE: 17-MAR-17
Kuro 3-Dong, Kuro_GU KR 152-769 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIMLRE F1 and CIMILRE S3
CIMILRE CO., LTD. 510(k) NO: K162870(Traditional)
ATTN: Ko Bong Jae PHONE NO : 82 31 7230941
#201, 202, Sagimakgol-ro 148, JungSE DECISION MADE: 07-MAR-17
Seongnam-si KR 13207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEP Monitor
TONICA ELEKTRONIK A/S 510(k) NO: K162873(Traditional)
ATTN: LISE TERKELSEN PHONE NO : 45 4 4998444
LUCERNEMARKEN 15 SE DECISION MADE: 31-MAR-17
Farum DK 3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIPCAM 1S 3D System
KARL STORZ Endoscopy America, Inc 510(k) NO: K162880(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E. Grand Avenue SE DECISION MADE: 16-MAR-17
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
STRAUMANN USA, LLC 510(k) NO: K162890(Traditional)
ATTN: JENNIFER M. JACKSON PHONE NO : 978 7472509
60 MINUTEMAN ROAD SE DECISION MADE: 08-MAR-17
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Olecranon Plating System
MIAMI DEVICE SOLUTIONS, LLC 510(k) NO: K162898(Traditional)
ATTN: Michelle Montesino PHONE NO : 786 4221400 106
7620 NW 25TH STREET UNIT 3 SE DECISION MADE: 17-MAR-17
MIAMI FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepWeaver 3D Nasal Mask
Circadiance, LLC 510(k) NO: K162905(Traditional)
ATTN: JAMES GIANOUTSOS PHONE NO : 724 8582837
1300 RODI RD SE DECISION MADE: 15-MAR-17
TURTLE CREEK PA 15145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexi-Seal PROTECT Fecal Management System
ConvaTec 510(k) NO: K162906(Traditional)
ATTN: Karen Howes PHONE NO : 44 0124 4832195
GDC, First Avenue, Deeside IndustrSE DECISION MADE: 07-MAR-17
Deeside GB ch5 2nu 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Male Latex Condoms
Zhejiang Xiangban Latex Products C510(k) NO: K162919(Traditional)
ATTN: Huichao Lou PHONE NO : 86 579 85420022
D288, Huancheng West Road, BeiyuanSE DECISION MADE: 07-MAR-17
Yiwu CN 322000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigated Instrument System
ORTHOFIX INC. 510(k) NO: K162921(Traditional)
ATTN: JACKI KOCH PHONE NO : 214 9372100
3451 PLANO PARKWAY SE DECISION MADE: 13-MAR-17
LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid2 Therapy System
MAGSTIM COMPANY LTD. 510(k) NO: K162935(Traditional)
ATTN: Kevyn Beard PHONE NO : 44 019 94240798
SPRING GARDENS SE DECISION MADE: 10-MAR-17
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
CHONGQING QMI SURGICAL CO., LTD 510(k) NO: K162947(Traditional)
ATTN: KANG LI PHONE NO : 86 23 67300630
A ZONE 1ST FLOOR, YANGLIU ROAD NO.SE DECISION MADE: 03-MAR-17
CHONGQING CN 401121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TotalC-Ram
ITENA CLINICAL 510(k) NO: K162960(Abbreviated)
ATTN: Charles Peyre PHONE NO : 33 145 913006
83 AVENUE FOCH SE DECISION MADE: 14-MAR-17
PARIS FR 75116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: nuance UNIVERSAL
Den-Mat Holdings, LLC 510(k) NO: K162967(Traditional)
ATTN: Helen Ragus PHONE NO : 805 3463700
1017 W. Central Avenue SE DECISION MADE: 24-MAR-17
Lompoc CA 93436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veloxion System
Corinth MedTech, Inc. 510(k) NO: K162979(Traditional)
ATTN: Sandeep Saboo PHONE NO : 408 9962517
1601 S. De Anza Blvd. Suite 221 SE DECISION MADE: 24-MAR-17
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ibis® Pedicle Screw System
Ortho Development Corporation 510(k) NO: K162995(Traditional)
ATTN: Lindsay Martin PHONE NO : 801 5539991
12187 South Business Park Drive SE DECISION MADE: 30-MAR-17
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
MICROVENTION, INC 510(k) NO: K162999(Traditional)
ATTN: Laraine Pangelina PHONE NO : 714 2478150
1311 VALENCIA AVENUE SE DECISION MADE: 29-MAR-17
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y3 Proximal Femoral Plate System
PEGA MEDICAL INC. 510(k) NO: K163003(Traditional)
ATTN: ARIEL R. DUJOVNE PHONE NO : 450 6885144
1111 AUTOROUTE CHOMEDEY SE DECISION MADE: 16-MAR-17
LAVAL CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
GMP MEDICARE SDN BHD 510(k) NO: K163017(Traditional)
ATTN: EVA VINONI BT MUSTAFA PHONE NO : 60 3 33926317
LOT/PT64593, JLN DAHLIA/KU8, KAW PSE DECISION MADE: 22-MAR-17
KLANG MY 41050 510(k) STATEMENT
DEVICE: ORTHOLOC® 3Di Small Bones Plating
Wright Medical Technology, Inc. 510(k) NO: K163039(Traditional)
ATTN: Michael Mullins PHONE NO : 901 8674142
1023 Cherry Road SE DECISION MADE: 13-MAR-17
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brevera Biopsy System with Corlumina Imaging Technology
HOLOGIC, INC. 510(k) NO: K163052(Traditional)
ATTN: SARAH FAIRFIELD PHONE NO : 508 2638857
250 CAMPUS DRIVE SE DECISION MADE: 29-MAR-17
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
OSPREY MEDICAL, INC. 510(k) NO: K163054(Traditional)
ATTN: MELANIE HESS PHONE NO : 952 9558252
5600 ROWLAND ROAD SUITE 250 SE DECISION MADE: 08-MAR-17
MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6200 Ultrasound System and 6250 Ultrasound System
ESAOTE S.P.A 510(k) NO: K163082(Traditional)
ATTN: MASSIMO POLIGNANO PHONE NO : 39 010 65471
VIA A. SIFFREDI 58 SE DECISION MADE: 16-MAR-17
GENOVA IT 16153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Blood Collection Set
Jiangsu Shenli Medical Production 510(k) NO: K163093(Traditional)
ATTN: Tina Cai PHONE NO : 86 519 88731071
No 20, Changzheng Road, Zhenglu SE DECISION MADE: 14-MAR-17
Changzhou City CN 213111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
GPC MEDICAL LIMITED 510(k) NO: K163096(Traditional)
ATTN: VIKAS NARANG PHONE NO : 91 11 43222600
GPC SQUARE, M-BLOCK, DDA, LSC, VIKSE DECISION MADE: 31-MAR-17
NEW DELHI IN 110018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: My Dose Coach
Sanofi, Inc. 510(k) NO: K163099(Traditional)
ATTN: Robert Ezzell PHONE NO : 617 7101418
640 Memorial Drive SE DECISION MADE: 22-MAR-17
Cambridge MA 02139 510(k) STATEMENT
DEVICE: Tranberg CLS Diffusor Laser Fiber
Clinical Laserthermia Systems AB 510(k) NO: K163103(Special)
ATTN: Lars-Erik Eriksson PHONE NO : 464 6152100
Scheelevagen 2 SE DECISION MADE: 23-MAR-17
Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxyHeal 4000 Multiplace Hyperbaric Chamber Family
OXYHEAL MEDICAL SYSTEMS, INC. 510(k) NO: K163109(Special)
ATTN: EDWARD J. CHOMAS PHONE NO : 619 3362022
3224 HOOVER AVE SE DECISION MADE: 22-MAR-17
NATIONAL CITY CA 91950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX Microwave Ablation System and Accessories
NEUWAVE MEDICAL, INC. 510(k) NO: K163118(Traditional)
ATTN: DAN KOSEDNAR PHONE NO : 608 5121592
3529 ANDERSON STREET SE DECISION MADE: 09-MAR-17
MADISON WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLENE Soft Polypropylene Mesh
Ethicon, Inc. 510(k) NO: K163152(Traditional)
ATTN: Debbie Fazen PHONE NO : 908 2183196
Route 22 West, P.O. Box 151 SE DECISION MADE: 11-MAR-17
Somerville NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartGrid
Carestream Health 510(k) NO: K163157(Traditional)
ATTN: Diane Koetter PHONE NO : 585 6276505
150 Verona Street SE DECISION MADE: 21-MAR-17
ROCHESTER NY 14468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Single-use Syringe with Needle
JiangXi HongDa Medical Equipment G510(k) NO: K163161(Traditional)
ATTN: Yang Xiaohua PHONE NO : 86 791 7918562891
No. 39 South Shengli Road, JinxianSE DECISION MADE: 20-MAR-17
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Safety Syringes for Single Use
JiangXi HongDa Medical Equipment G510(k) NO: K163162(Traditional)
ATTN: Yang Xiaohua PHONE NO : 86 21 85628918
No. 39 South Shengli Road, JinxianSE DECISION MADE: 20-MAR-17
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bel-Cypher Pro
Takara Belmont Corporation 510(k) NO: K163175(Traditional)
ATTN: Toshinori Kiyomatsu PHONE NO : 81 6 62135945
1-1-2 Chome, Higashi-Shinsaibashi,SE DECISION MADE: 20-MAR-17
Osaka JP 542-0083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
Medtronic Powered Surgical Solutio510(k) NO: K163182(Traditional)
ATTN: Deep Pal PHONE NO : 817 7886685
4620 North Beach Street SE DECISION MADE: 23-MAR-17
Fox Worth TX 76177 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Next Science Wound Gel (Rx)
Next Science, LLC 510(k) NO: K163188(Traditional)
ATTN: Matthew Myntti PHONE NO : 855 5642762
8130 Baymeadows Way W, Suite 200 SE DECISION MADE: 06-MAR-17
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYMCO EQ10D Scooter
KWANG YANG MOTOR CO., LTD. 510(k) NO: K163201(Traditional)
ATTN: Wang Ching Yun PHONE NO : 886 7 3822526
No. 35, Wan Hsing Street, San Min SE DECISION MADE: 16-MAR-17
Kaohsiung TW 803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ SOLO Sensor
Jazz Imaging LLC 510(k) NO: K163224(Traditional)
ATTN: Todd C. Miller PHONE NO : 650 9990909
800 Charcot Avenue, Suite 100 SE DECISION MADE: 09-MAR-17
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus XLIF Interbody System
NUVASIVE INCORPORATED 510(k) NO: K163230(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 LUSK BLVD. SE DECISION MADE: 16-MAR-17
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTmatic
Kaltenbach & Voigt GmbH 510(k) NO: K163239(Traditional)
ATTN: Stefan Trampler PHONE NO : 49 7351 563515
Bismarckring 39 SE DECISION MADE: 17-MAR-17
Biberach DE 88400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
LAURIMED LLC 510(k) NO: K163247(Traditional)
ATTN: Brian R DuBois PHONE NO : 650 5875296
500 ARGUELLO ST., SUITE 100 SE DECISION MADE: 09-MAR-17
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation 510(k) NO: K163248(Traditional)
ATTN: Yingying Gao PHONE NO : 508 6834356
100 Boston Scientific Way SE DECISION MADE: 27-MAR-17
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GoSpiro
MONITORED THERAPEUTICS, INC. 510(k) NO: K163249(Traditional)
ATTN: William Zimlich PHONE NO : 614 7613555
5940 VENTURE DR., SUITE C SE DECISION MADE: 24-MAR-17
DUBLIN OH 43017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVE
BRIGHTWAY HOLDINGS SDN BHD 510(k) NO: K163267(Traditional)
ATTN: G. BASKARAN PHONE NO : 603 3 3431007
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 24-MAR-17
KLANG MY 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo. CT Neuro Perfusion
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163284(Traditional)
ATTN: KIMBERLY MANGUM PHONE NO : 610 4486477
40 LIBERTY BLVD. MAIL CODE 65-1A SE DECISION MADE: 01-MAR-17
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS pheno
SIEMENS MEDICAL SOLUTION USA, INC.510(k) NO: K163286(Traditional)
ATTN: PATRICIA D. JONES PHONE NO : 610 4486474
40 LIBERTY BOULEVARD 65-1A SE DECISION MADE: 09-MAR-17
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITT ULite
INFINITT CO., LTD. 510(k) NO: K163290(Special)
ATTN: Heejin Lim PHONE NO : 82 2 21946923
12FI Daerung Post Tower III, 27 DiSE DECISION MADE: 24-MAR-17
Seoul KR 152-746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM go.Up, SOMATOM go.Now
Siemens Medical Solutions USA, Inc510(k) NO: K163296(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 448 6477
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 21-MAR-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K163297(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 24-MAR-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermoShield HME Filter
Flexicare Medical Limited 510(k) NO: K163300(Third Party - Traditional)
ATTN: Joel Biddle PHONE NO : 44 1443 474647
Cynon Valley Business Park SE DECISION MADE: 22-MAR-17
Mountain Ash GB cf45 4ER 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Expro Elite Snare, Sympro Elite Snare
Vascular Solutions, Inc. 510(k) NO: K163307(Traditional)
ATTN: Jake Schultz PHONE NO : 763 6564300
6464 Sycamore Court North SE DECISION MADE: 08-MAR-17
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
Boston Scientific Corporation 510(k) NO: K163314(Traditional)
ATTN: Nikki Wahlberg PHONE NO : 763 4942381
Two Scimed Place SE DECISION MADE: 23-MAR-17
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP-Pump PP110
W.O.M. WORLD OF MEDICINE GMBH 510(k) NO: K163320(Traditional)
ATTN: Soeren Markworth PHONE NO : 0049 30 39981594
SALZUFER 8 SE DECISION MADE: 21-MAR-17
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dolphix® External Fixation System MR Conditional
CITIEFFE s.r.l 510(k) NO: K163323(Traditional)
ATTN: Stefano Pullega PHONE NO : 39 051 721850
Via Armaroli, 21 SE DECISION MADE: 20-MAR-17
Calderara di Reno IT 400012 510(k) STATEMENT
DEVICE: Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
GE Medical Systems, LLC 510(k) NO: K163331(Traditional)
ATTN: Mary A. Mayka PHONE NO : 262 5273148
3200 Grandview Blvd SE DECISION MADE: 17-MAR-17
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Icare HOME tonometer
Icare Finland Oy 510(k) NO: K163343(Traditional)
ATTN: Matti Tulikoura PHONE NO : 358 9 87751150
Ayritie 22 SE DECISION MADE: 21-MAR-17
Vantaa FI 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAZIC Duro
VERICOM CO., LTD. 510(k) NO: K163346(Traditional)
ATTN: Myung-Hwan Oh PHONE NO : 82 31 4412881
48 Toegyegongdan 1-gil SE DECISION MADE: 17-MAR-17
Chuncheon-si KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multibase Abutments EV and ATLANTIS Suprastructures
DENTSPLY SIRONA 510(k) NO: K163350(Traditional)
ATTN: KARL NITTINGER PHONE NO : 717 8494424
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 31-MAR-17
York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOJAVE Expandable Interbody System
K2M 510(k) NO: K163364(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 15-MAR-17
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mikro-Cath Pressure Catheter
Millar, Inc. 510(k) NO: K163376(Traditional)
ATTN: Jacqueline Jean-Baptiste PHONE NO : 832 6677000
6001-A Gulf Freeway SE DECISION MADE: 10-MAR-17
Houston TX 77023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Airway Clearance System
HILL-ROM SERVICES PTE LTD 510(k) NO: K163378(Traditional)
ATTN: Huifang Zhu PHONE NO : 65 6 4997395
1 YISHUN AVE 7 SE DECISION MADE: 17-MAR-17
Singapore SG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KneeAlign 2 System
OrthAlign, Inc. 510(k) NO: K163379(Traditional)
ATTN: David Vancelette PHONE NO : 949 7152424
120 Columbia, Suite 500 SE DECISION MADE: 02-MAR-17
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nix Ultra Lice Treatment Kit
MEDTECH PRODUCTS INC. 510(k) NO: K163401(Traditional)
ATTN: JEAN BOYKO PHONE NO : 914 5246894
660 WHITE PLAINS ROAD SE DECISION MADE: 21-MAR-17
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 360KS Implant Positioning System
Kico Knee Innovation Company PTY L510(k) NO: K163405(Traditional)
ATTN: Karl Rentsch PHONE NO : 61 408 419070
Suite 3, Building 1, 20 Bridge StrSE DECISION MADE: 21-MAR-17
Pymble AU 2073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart(TM) T Lumbar Interbody Fusion Device
Spineology Inc. 510(k) NO: K163409(Traditional)
ATTN: Jacqueline A. Hauge PHONE NO : 651 2568500
7800 3rd Street North, Suite 600 SE DECISION MADE: 08-MAR-17
St. Paul MN 55128-5455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
NARANG MEDICAL USA CORPORATION 510(k) NO: K163425(Traditional)
ATTN: Reginald Swift PHONE NO : 978 6556770
15951 SW 41 ST SUITE 800B SE DECISION MADE: 24-MAR-17
DAVIE FL 33331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Greiner Vacuette Urine Count and Culture, Mannitol tube
GREINER BIO-ONE NA INC. 510(k) NO: K163436(Traditional)
ATTN: MANFRED ABEL PHONE NO : 704 2617823
4238 CAPITAL DRIVE SE DECISION MADE: 06-MAR-17
MONROE NC 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVA combo RF System
STARmed Co., Ltd. 510(k) NO: K163450(Traditional)
ATTN: Jun-Young Jung PHONE NO : 82 70 46738628
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 08-MAR-17
Gyeonggi-do KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kalitec Direct InSePtion™ MIS Fixation System
KALITEC DIRECT, LLC 510(k) NO: K163471(Traditional)
ATTN: KEITH CANNAN PHONE NO : 407 5452063 103
618 E. SOUTH STREET SUITE 500 SE DECISION MADE: 16-MAR-17
ORLANDO FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAVUX CervicalCage-L SA System
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K163474(Traditional)
ATTN: EDWARD LIOU PHONE NO : 415 9239376
1331 N. CALIFORNIA BLVD SUITE 320 SE DECISION MADE: 10-MAR-17
WALNUT CREEK CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex-Thread Clavicle Pin System
INTRAFUSE LLC 510(k) NO: K163488(Traditional)
ATTN: Robert Hoy PHONE NO : 614 4486358
124 S 600W, SUITE 100 SE DECISION MADE: 20-MAR-17
LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoSolutions 'System26' Bone Screws
Ortho SOlutions UK Limited 510(k) NO: K163489(Traditional)
ATTN: Craig Bluett PHONE NO : 016 21 843599
West Station Business Park, SpitalSE DECISION MADE: 08-MAR-17
Maldon GB CM9 6FF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive CoRoent Small Interbody System
NuVasive, Incorporated 510(k) NO: K163491(Traditional)
ATTN: Martin Yahiro PHONE NO : 858 6385589
7475 Lusk Boulevard SE DECISION MADE: 24-MAR-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AdvanCE capsule endoscope delivery device
United States Endoscopy Group, Inc510(k) NO: K163495(Traditional)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 10-MAR-17
Mentor OH 44060 510(k) STATEMENT
DEVICE: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
ENCORE MEDICAL, L.P. 510(k) NO: K163497(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 METRIC BLVD. SE DECISION MADE: 02-MAR-17
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE Heparin Calibration Verification/Linearity Test Kit
MAINE STANDARDS COMPANY, LLC 510(k) NO: K163498(Traditional)
ATTN: JAMES CHAMPLIN PHONE NO : 207 8921300
221 US Route 1 SE DECISION MADE: 16-MAR-17
Cumberland Foreside ME 04110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
LIOFILCHEM S.R.L. 510(k) NO: K163517(Traditional)
ATTN: FABIO BROCCO PHONE NO : 39 085 8930745
VIA SCOZIA ZONA IND. LE SE DECISION MADE: 14-MAR-17
ROSETO DEGLI ABRUZZI IT 64026 510(k) STATEMENT
DEVICE: FilmArray Warrior Control Panel M290
Maine Molecular Quality Controls, 510(k) NO: K163522(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 14-MAR-17
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITACHI Supria Whole-body X-ray CT System Phase 3
Hitachi Medical Systems America, I510(k) NO: K163528(Abbreviated)
ATTN: Doug Thistlethwaite PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 03-MAR-17
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
AVERY DENNISON CORPORATION 510(k) NO: K163529(Traditional)
ATTN: LISA BARTAKOVICS PHONE NO : 440 5346000
7100 Lindsay Dr Bldg 14 SE DECISION MADE: 29-MAR-17
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iPulse SmoothSkin BARE Hair Removal Device
CYDEN LIMITED 510(k) NO: K163552(Special)
ATTN: MIKE KIERNAN PHONE NO : 44 179 2485519
TECHNIUM 2, KINGS ROAD SE DECISION MADE: 03-MAR-17
SWANSEA GB SA1 8PJ 510(k) STATEMENT
DEVICE: Synapsys Ulmer Video Nystagmograph
Synapsys SA 510(k) NO: K163558(Special)
ATTN: Laetitia Baconnier PHONE NO : 33 4 91117575
SE DECISION MADE: 23-MAR-17
Marseille FR 13013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-GN Gentamicin (<=1 –="">=16 µg/mL)
bioMerieux, Inc 510(k) NO: K163563(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 13-MAR-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR8 Drill System
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K163565(Traditional)
ATTN: Deep Pal PHONE NO : 817 7886400
4620 NORTH BEACH ST. SE DECISION MADE: 28-MAR-17
FORT WORTH TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys CMV IgM
Roche Diagnostics 510(k) NO: K163569(Traditional)
ATTN: Angelo Pereira PHONE NO : 317 5213544
9115 Hague Rd. SE DECISION MADE: 17-MAR-17
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
LV Liberty Vision Corp. 510(k) NO: K163572(Traditional)
ATTN: Paul T. Finger PHONE NO : 603 7660451
155 Fleet Street SE DECISION MADE: 15-MAR-17
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inqwire Diagnostic Guide Wire
Merit Medical Systems, Inc. 510(k) NO: K163575(Special)
ATTN: Mark Mullaney PHONE NO : 353 91 703700 3061
Parkmore Business Park West SE DECISION MADE: 03-MAR-17
Galway IE N-A 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
TrovRx, Inc. dba Trovita Health Sc510(k) NO: K163586(Traditional)
ATTN: William Brown PHONE NO : 908 9387534
230 South Broad Street, 17th FloorSE DECISION MADE: 17-MAR-17
Philadelphia PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Incubator for Assert Self Contained Biological Indicators
STERIS Corporation 510(k) NO: K163587(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5976 Heisley Rd SE DECISION MADE: 24-MAR-17
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine® Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation 510(k) NO: K163604(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 09-MAR-17
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
BioStable Science & Engineering In510(k) NO: K163608(Traditional)
ATTN: Julie Thomas PHONE NO : 512 9709112
2621 Ridgepoint Dr., Suite 100 SE DECISION MADE: 21-MAR-17
Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd. 510(k) NO: K163629(Traditional)
ATTN: Robert Burda PHONE NO : 760 4317922
230 Technology Parkway SE DECISION MADE: 10-MAR-17
Eatonton GA 31024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
BECTON, DICKINSON & COMPANY 510(k) NO: K163637(Traditional)
ATTN: MONICA E. GIGUERE PHONE NO : 410 3164287
7 LOVETON CIRCLE MC 694 SE DECISION MADE: 21-MAR-17
SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureSigns VS3; SureSigns VS4
Philips Medical Systems 510(k) NO: K163649(Special)
ATTN: Greg Li PHONE NO : 978 6594227
3000 Minuteman Rd. SE DECISION MADE: 31-MAR-17
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
Covidien llc 510(k) NO: K163654(Traditional)
ATTN: Gary LeMere PHONE NO : 203 4925572
60 Middletown Avenue SE DECISION MADE: 08-MAR-17
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sparkling
Shanghai Wonderful Opto-Electrics 510(k) NO: K163655(Traditional)
ATTN: Amy Lee PHONE NO : 0086 21 62642623
2F, Building 3, Lane 561, Nujiang SE DECISION MADE: 17-MAR-17
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc. 510(k) NO: K163700(Traditional)
ATTN: Marc Chaunet PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 29-MAR-17
Quebec City CA g1n 4rY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophageal Cooling Device
ADVANCED COOLING THERAPY, LLC 510(k) NO: K170009(Traditional)
ATTN: Erik Kulstad PHONE NO : 312 7254756
3440 S. Dearborn St. #215-South SE DECISION MADE: 30-MAR-17
Chicago IL 60616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATECH TALCAIR
NOVATECH S.A. 510(k) NO: K170030(Traditional)
ATTN: JENNIFER NEFF PHONE NO : 33 044 2981560
Z.I. ATHELIA III - 1058, VOIE ANTISE DECISION MADE: 13-MAR-17
LA CIOTAT CEDEX FR 13705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraView TBI
Cablon Medical B.V. 510(k) NO: K170058(Special)
ATTN: Jurjen Weistra PHONE NO : 31 33 4943964
Klepelhoek 11 SE DECISION MADE: 03-MAR-17
Leusden NL 3833 GZ 510(k) STATEMENT
DEVICE: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
Siemens Healthcare Diagnostics, In510(k) NO: K170065(Traditional)
ATTN: Julie Warren PHONE NO : 302 6318722
511 Benedict Avenue SE DECISION MADE: 09-MAR-17
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUOFUCON Silicone Ag Foam Dressing with Border
HUIZHOU FORYOU MEDICAL DEVICES Co.510(k) NO: K170077(Traditional)
ATTN: Guosheng Tan PHONE NO : 86 0752 5302012
NORTH SHANGXIA ROAD DONGJIANG HI-TSE DECISION MADE: 30-MAR-17
HUIZHOU CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InterLock Trocar
FUJIFILM New Development U.S.A., I510(k) NO: K170084(Traditional)
ATTN: Stephen Mariano PHONE NO : 781 8602463
318 Bear Hill Road, Suite 10 SE DECISION MADE: 10-MAR-17
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial2Bag Direct Connect
Medimop Medical Project Ltd. 510(k) NO: K170095(Special)
ATTN: Ilanit Goldgraber PHONE NO : 972 9 7757122
17 Hatidhar St. SE DECISION MADE: 08-MAR-17
Ra'anana IL 43665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONIX TT All Suture Anchor
Stryker 510(k) NO: K170098(Special)
ATTN: Taylor White PHONE NO : 303 3367285
5670 Greenwood Plaza Blvd., Suite SE DECISION MADE: 31-MAR-17
Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermi Injectable RF Electrodes
Thermi 510(k) NO: K170116(Traditional)
ATTN: Suzanne Cheang PHONE NO : 214 8880683
8304 Esters Boulevard SE DECISION MADE: 13-MAR-17
IRVING TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Level One Hand Plating System
KLS MARTIN LP 510(k) NO: K170124(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 09-MAR-17
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Reline® 4.5-5.0 System
NUVASIVE, INCORPORATED 510(k) NO: K170126(Traditional)
ATTN: Olga Lewis PHONE NO : 858 3205488
7475 LUSK BLVD. SE DECISION MADE: 09-MAR-17
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
Hardy Diagnostics 510(k) NO: K170127(Traditional)
ATTN: Rianna Malherbe PHONE NO : 805 3462766 5714
1430 West McCoy Lane SE DECISION MADE: 14-MAR-17
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: New Deantronics E Green™ Electrosurgical Monopolar Pencils
New Deantronics Taiwan, LTD 510(k) NO: K170161(Traditional)
ATTN: Jane Liu PHONE NO : 886 2 22681726
12F,No.51,Sec.4, Chong Yang Road, SE DECISION MADE: 29-MAR-17
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D OCT-1 Maestro
Topcon Corporation 510(k) NO: K170164(Special)
ATTN: James Lorkowski PHONE NO : 201 5995283
75-1 Hasunuma-cho, Itabashi-ku SE DECISION MADE: 03-MAR-17
Tokyo JP 174-8580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True 3D Viewer Software
EchoPixel Inc. 510(k) NO: K170167(Third Party - Special)
ATTN: Sergio Aguirre PHONE NO : 650 4047097
2490 Hospital Drive, Suite 310 SE DECISION MADE: 03-MAR-17
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
Bovie Medical Corporation 510(k) NO: K170188(Traditional)
ATTN: Rubiela Maldonado PHONE NO : 727 8038508
5115 Ulmerton Road SE DECISION MADE: 08-MAR-17
Clearwater FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FFR Link, FFR Signal Processing Module
Boston Scientific Corporation 510(k) NO: K170204(Traditional)
ATTN: Dan Krause PHONE NO : 510 2400048
47215 Lakeview Blvd. SE DECISION MADE: 24-MAR-17
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA IS TLIF & DLIF Cages
CORENTEC CO., LTD 510(k) NO: K170243(Special)
ATTN: J.S. DANIEL PHONE NO : 82 415 857144
12, YEONGSANHONG 1-GIL, IPJANG-MYESE DECISION MADE: 31-MAR-17
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BGM009 Plus Blood Glucose Monitoring System
Apex Bio Technology Corp. 510(k) NO: K170267(Special)
ATTN: Hsue-mei Lee PHONE NO : 011 886 35641952
No. 7, Li-Hsin Road V Hsinchu ScieSE DECISION MADE: 09-MAR-17
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive(r) Monolith Corpectomy System
NuVasive, Incorporated 510(k) NO: K170271(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 Lusk Boulevard SE DECISION MADE: 30-MAR-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K170277(Traditional)
ATTN: YANG ZHAOHUI PHONE NO : 86 755 81885640
KEJI 12TH ROAD SOUTH, HI-TECH INDUSE DECISION MADE: 23-MAR-17
SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Great Basin Bordetella Direct Test
GREAT BASIN SCIENTIFIC, INC. 510(k) NO: K170284(Traditional)
ATTN: SUZETTE CHANCE PHONE NO : 385 2153369
2441 S. 3850 WEST SUITE 100 SE DECISION MADE: 31-MAR-17
SALT LAKE CITY UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreCath 2.7S
Medtronic Advanced Energy 510(k) NO: K170296(Traditional)
ATTN: Lydia Sakakeeny PHONE NO : 603 2945482
180 International Drive SE DECISION MADE: 20-MAR-17
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alians Clavicle range
Newclip Technics 510(k) NO: K170310(Traditional)
ATTN: Gaelle Lussori PHONE NO : 33 2 28213712
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 30-MAR-17
Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL AcuStar
INSTRUMENTATION LABORATORY CO. 510(k) NO: K170314(Special)
ATTN: NIKITA MALLADI PHONE NO : 781 6743245
180 HARTWELL ROAD SE DECISION MADE: 03-MAR-17
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus SLiK Anchors
Parcus Medical 510(k) NO: K170327(Traditional)
ATTN: Paul Vagts PHONE NO : 941 7557965
6423 Parkland Dr SE DECISION MADE: 30-MAR-17
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Basic, Dominant Flex
Modela AG 510(k) NO: K170329(Traditional)
ATTN: Markus Butler PHONE NO : 41 041 5616671
Lattichstrasse 4b SE DECISION MADE: 24-MAR-17
Baar CH 6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cyber Ho
quanta system spa 510(k) NO: K170331(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 033 1376797
via acquedotto 109 SE DECISION MADE: 03-MAR-17
samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Canon, Inc. 510(k) NO: K170332(Traditional)
ATTN: SHINJI MORI PHONE NO : 81 3 37582111
9-1, Imaikami-Cho SE DECISION MADE: 01-MAR-17
NAKAHARA-ku, KAWASAKI JP 211-8501510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
Valley Contax, Inc. 510(k) NO: K170335(Traditional)
ATTN: Josh Adams PHONE NO : 800 5478815___
200 S Mill St SE DECISION MADE: 24-MAR-17
Springfield OR 97477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
Becton, Dickinson and Company 510(k) NO: K170336(Third Party - Traditional)
ATTN: Kimberly Geisler PHONE NO : 801 5652300
9450 South State Street SE DECISION MADE: 10-MAR-17
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRECICE Intramedullary Limb Lengthening System
NuVasive Specialized Orthopedics, 510(k) NO: K170346(Traditional)
ATTN: Lance Justice PHONE NO : 949 8373600
101 Enterprise, Suite 100 SE DECISION MADE: 07-MAR-17
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signia Four-Bay Smart Charger (to be used with Signia Stapler)
Covidien 510(k) NO: K170348(Special)
ATTN: Katherine Y. Choi PHONE NO : 203 4928412
60 Middletown Avenue SE DECISION MADE: 02-MAR-17
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ToeMATE® Hammertoe Correction System
Arthrosurface, Inc. 510(k) NO: K170350(Special)
ATTN: Phani Puppala PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 03-MAR-17
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation 6
RaySearch Laboratories AB (publ) 510(k) NO: K170355(Traditional)
ATTN: David Hedfors PHONE NO : 46 722 366110
Sveav 44 SE DECISION MADE: 02-MAR-17
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSiStim-PP
DyAnsys Inc 510(k) NO: K170391(Special)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 09-MAR-17
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CenterCross Ultra LV Catheter
Roxwood Medical, Inc. 510(k) NO: K170403(Special)
ATTN: Mehrdad Farhangnia PHONE NO : 408 3734751
400 Seaport Ct, Suite 103 SE DECISION MADE: 07-MAR-17
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: n!ce Glass Ceramic Blocks for Amann Girrbach
Institut Straumann AG 510(k) NO: K170420(Special)
ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260
Peter Merian Weg 12 SE DECISION MADE: 02-MAR-17
Basel CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One Surgical System Model 210
THINK Surgical Inc. 510(k) NO: K170430(Special)
ATTN: In K. Mun PHONE NO : 510 2492300
47320 Mission Falls Court SE DECISION MADE: 06-MAR-17
Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
Millennium Medical Technologies, I510(k) NO: K170449(Traditional)
ATTN: Jim Barley PHONE NO : 949 4333058
6352 Corte Del Abeto Suite A SE DECISION MADE: 31-MAR-17
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDX Console (DR-ID300CL) Software
FUJIFILM Medical Systems U.S.A., I510(k) NO: K170451(Traditional)
ATTN: Peter Altman PHONE NO : 203 6023576
419 West Avenue SE DECISION MADE: 16-MAR-17
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Anterior Stand Alone
Medacta International SA 510(k) NO: K170455(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 16-MAR-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nio Color 5.8MP (MDNC-6121)
Barco NV 510(k) NO: K170476(Special)
ATTN: Helena Soenen PHONE NO : 32 56 233528
President Kennedypark 35 SE DECISION MADE: 28-MAR-17
Kortrijk BE 8500 510(k) STATEMENT
DEVICE: HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K170493(Third Party - Traditional)
ATTN: Jiyeon Cho PHONE NO : 82 2 21945431
42, Teheran-ro 108-gil, Gangnam-guSE DECISION MADE: 28-MAR-17
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
ConMed Corporation 510(k) NO: K170501(Special)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995425
525 French Road SE DECISION MADE: 17-MAR-17
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
Intuitive Surgical, Inc. 510(k) NO: K170508(Traditional)
ATTN: Cheryl Wu PHONE NO : 408 5236401
1266 Kifer Road SE DECISION MADE: 10-MAR-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Titanium Interbody Fusion System
Altus Partners, LLC 510(k) NO: K170512(Special)
ATTN: Claudia Hill PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 10-MAR-17
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Alcon Research, Ltd. 510(k) NO: K170520(Special)
ATTN: Karen Mudd PHONE NO : 949 5057269
20511 Lake Forest Drive SE DECISION MADE: 22-MAR-17
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterispine™ PS
SAFE ORTHOPAEDICS 510(k) NO: K170528(Special)
ATTN: Pierre Dumouchel PHONE NO : 330 134 215000
PARC DES BELLEVUES Allee R. LuxembSE DECISION MADE: 09-MAR-17
Eragny Sur Oise FR 95610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Butrex Lumbar Buttress Plating System
X-Spine Systems, Inc. 510(k) NO: K170530(Special)
ATTN: Kriss Anderson PHONE NO : 937 8478400 2137
452 Alexandersville Rd SE DECISION MADE: 22-MAR-17
Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
Avitus Orthopaedics, Inc 510(k) NO: K170539(Special)
ATTN: Maxim Budyansky PHONE NO : 860 4046476
400 Farmington Ave Suite R2826, CBSE DECISION MADE: 20-MAR-17
Farmington CT 06032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Medtronic, Inc. 510(k) NO: K170583(Special)
ATTN: Gayatri Ghadge PHONE NO : 763 5269336
7611 Northland Drive SE DECISION MADE: 17-MAR-17
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
Cook Incorporated 510(k) NO: K170622(Special)
ATTN: Naomi Funkhouser PHONE NO : 812 3392235 104371
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 31-MAR-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioMonitor 2-AF, BioMonitor 2-S
BIOTRONIK, Inc 510(k) NO: K170628(Special)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 31-MAR-17
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chameleon PTA Balloon Catheter
AV Medical Technologies Ltd 510(k) NO: K170635(Special)
ATTN: Limor Sandach PHONE NO : 972 775 055645
21 B Habarzel Street SE DECISION MADE: 30-MAR-17
Tel-Aviv IL 6971029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fathom-16 Steerable Guidewires
Boston Scientific Corporation 510(k) NO: K170636(Special)
ATTN: Keith Neligan PHONE NO : 00353 21 4531786
Three Scimed Place SE DECISION MADE: 22-MAR-17
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USS System
Synthes USA Products LLC 510(k) NO: K170654(Special)
ATTN: Eugene Bang PHONE NO : 508 9773966
325 Paramount Drive SE DECISION MADE: 29-MAR-17
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN_2 and GEN_3 Mechanical Wheelchairs
Free Wheelchair Mission 510(k) NO: K170701(Special)
ATTN: Don Schoendorfer PHONE NO : 949 2738470
15279 Alton Parkway Suite 300 SE DECISION MADE: 24-MAR-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AngioDynamics Total Abscession Biliary Drainage Catheter
AngioDynamics, Inc. 510(k) NO: K170743(Special)
ATTN: Teri Juckett PHONE NO : 518 7951142
603 Queensbury Avenue SE DECISION MADE: 30-MAR-17
Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX50N(CX50YQS)
WIDE Corporation 510(k) NO: K170783(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 312 181675
12 Wongomae-Ro, Giheung-Gu SE DECISION MADE: 31-MAR-17
Yongin-Si KR 17086 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 272
TOTAL WITH SUMMARIES 251
TOTAL WITH STATEMENTS 21
