510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2017
DEVICE: Resultz Lice & Egg Removal Kit
Piedmont Pharmaceuticals, LLC 510(k) NO: K151562(Traditional)
ATTN: Kathleen G. Palma PHONE NO : 336 5540320
204 Muirs Chapel Road, Ste 200 SE DECISION MADE: 08-MAY-17
Greensboro NC 27410 510(k) STATEMENT
DEVICE: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
3M COMPANY 510(k) NO: K153410(Traditional)
ATTN: Melissa Forth PHONE NO : 651 7375016
3M CENTER, 2510 CONWAY AVE, BLDG 2SE DECISION MADE: 15-MAY-17
ST.PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirLife Misty Finity Nebulizer
CareFusion 510(k) NO: K153748(Traditional)
ATTN: Erika Fernandez PHONE NO : 847 3628097
75 N Fairway Drive SE DECISION MADE: 17-MAY-17
Vernon Hills IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
THAYER MEDICAL CORPORATION 510(k) NO: K160109(Traditional)
ATTN: MEGHAN MCGOVERN PHONE NO : 520 7905393
4575 SOUTH PALO VERDE ROAD SUITE 3SE DECISION MADE: 19-MAY-17
TUCSON AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI Compatibility for Existing Zimmer Dental Implant Systems
Zimmer Dental, Inc. 510(k) NO: K160398(Traditional)
ATTN: Alex Eastes PHONE NO : 760 9294300
1900 Aston Ave. SE DECISION MADE: 17-MAY-17
Carlsbad CA 92008 510(k) STATEMENT
DEVICE: Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
COOK INCORPORATED 510(k) NO: K160509(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
750 DANIELS WAY SE DECISION MADE: 18-MAY-17
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barone Jejunostomy Catheter Set
COOK INCORPORATED 510(k) NO: K160567(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
750 DANIELS WAY SE DECISION MADE: 18-MAY-17
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anybattery C2 Rechargeable Battery
Anybattery, Inc. 510(k) NO: K160667(Traditional)
ATTN: Ed Speegle PHONE NO : 651 4230555
2605 160th Street W #16 SE DECISION MADE: 11-MAY-17
Rosemont MN 55068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRORUPTOR 6
MERIDIAN AG 510(k) NO: K160677(Traditional)
ATTN: FRANZISKA GOTSCHI PHONE NO : 41 33 3341111
BIERIGUTSTRASSE 7 SE DECISION MADE: 19-MAY-17
THUN CH CH-3608 510(k) STATEMENT
DEVICE: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
SEMPERIT INVESTMENTS ASIA PTE. LTD510(k) NO: K160781(Abbreviated)
ATTN: CLEMENS EICHLER PHONE NO : 65 597 207805
8 Jurong Town Hall Road #29 - 03 TSE DECISION MADE: 02-MAY-17
SINGAPORE SG 609434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINISCAV
Sedation Systems LLC 510(k) NO: K160950(Traditional)
ATTN: S. Michael Bender PHONE NO : 888 9595288
2471 McMullen Booth Rd, Ste. 316 SE DECISION MADE: 05-MAY-17
Clearwater FL 33759 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
Genea Biomedx Pty Ltd 510(k) NO: K161261(Traditional)
ATTN: Kea Dent PHONE NO : 61 2 84847677
Level 2, 321 Kent Street SE DECISION MADE: 12-MAY-17
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Supreme and Response Electrophysiology Catheters
Surgical Instrument Service and Sa510(k) NO: K161272(Traditional)
ATTN: Brandi J. Panteleon PHONE NO : 541 9233310
(dba Medline ReNewal) 2747 SW 6th SE DECISION MADE: 18-MAY-17
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamika
IMAGE ANALYSIS LIMITED 510(k) NO: K161601(Traditional)
ATTN: Mark Hinton PHONE NO : 44 207 6309926
QABC MINSTER HOUSE, 272-274 VAUXHASE DECISION MADE: 17-MAY-17
London GB SW1V 1BA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTEM Implant System - Abutment
OSSTEM IMPLANT Co., Ltd. 510(k) NO: K161689(Traditional)
ATTN: Hee Kwon PHONE NO : 82 51 8502575
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 22-MAY-17
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rusch Silicone Foley Catheter
Teleflex Medical, Inc. 510(k) NO: K161770(Traditional)
ATTN: Lori Pfohl PHONE NO : 919 4918960
2917 Weck Drive SE DECISION MADE: 05-MAY-17
Research Triangle Park NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iGlucose Blood Glucose Monitoring System
BIONIME CORPORATION 510(k) NO: K161790(Traditional)
ATTN: Tino Lee PHONE NO : 886 4 23692388
NO. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 02-MAY-17
Taichung City TW 40242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAMSCAN
PTW-Freiburg Physikalisch Technisc510(k) NO: K161807(Traditional)
ATTN: Sandor-Csaba Ats PHONE NO : 49 761 49055896
Dr. Pychlau GmbH Loerracher Str. 7SE DECISION MADE: 19-MAY-17
Freiburg DE 79115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frova Intubating Introducer
WILLIAM COOK EUROPE APS 510(k) NO: K161813(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 5686 8756
SANDET 6 SE DECISION MADE: 19-MAY-17
BJAEVERSKOV DK 4632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVE POWDER FREE
CAREGLOVE GLOBAL SDN BHD 510(k) NO: K161833(Traditional)
ATTN: LIM KWEE SHYAN PHONE NO : 60 667 82377
LOT 17479, LRG SENAWANG 3/2, OFF JSE DECISION MADE: 23-MAY-17
SEREMBAN MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter
XUZHOU YONGKANG ELECTRONIC SCIENCE510(k) NO: K161938(Traditional)
ATTN: YANLI LI PHONE NO : 86 516 87892766 631
4F BUILDING C8, 40 JINGSHAN ROAD, SE DECISION MADE: 08-MAY-17
XUZHOU CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K161950(Traditional)
ATTN: Keshin Hu PHONE NO : 86 571 86775619
No. 18 Haishu Road Future Sci-TechSE DECISION MADE: 11-MAY-17
Hangzhou CN ZJ571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniTex Non-Sterile, Powder-Free, Latex Examination Glove
UG GLOBAL RESOURCES SDN BHD 510(k) NO: K161961(Traditional)
ATTN: Wong See Keong PHONE NO : 60 06 6772751
Lot 62 & 63, Lorong Senawang 3/2 KSE DECISION MADE: 11-MAY-17
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airworks Nebulizer pe1200m
Convexity Scientific LLC 510(k) NO: K162041(Traditional)
ATTN: Paul Reiferson PHONE NO : 203 5576254
36 Church Lane SE DECISION MADE: 02-MAY-17
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALUC™ Total Hip Arthroplasty System
SurgTech, Inc., 510(k) NO: K162125(Traditional)
ATTN: Xuegong Yu PHONE NO :
24600 Center Ridge Road, Suite 195SE DECISION MADE: 10-MAY-17
Westlake OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExSpiron 1Xi
Respiratory Motion Inc. 510(k) NO: K162131(Traditional)
ATTN: Edwin Rule PHONE NO : 781 3731636
411 Waverly Oaks Road, Building 1,SE DECISION MADE: 09-MAY-17
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VerteFIT Corpectomy Cage System
LDR SPINE USA, INC. 510(k) NO: K162133(Traditional)
ATTN: JAMIE WILSON PHONE NO : 512 3443355
13785 RESEARCH BLVD SUITE 200 SE DECISION MADE: 16-MAY-17
AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restore Moisturizing Vaginal Lubricant
Good Clean Love 510(k) NO: K162207(Traditional)
ATTN: Wendy Strgar PHONE NO : 541 3444483
207 West 5th Avenue SE DECISION MADE: 04-MAY-17
Eugene OR 97401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K162212(Traditional)
ATTN: LEE GRANT PHONE NO : 901 3440807
1800 PYRAMID PLACE SE DECISION MADE: 19-MAY-17
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Asahi ViE-U Series Dialyzer
ASAHI KASEI MEDICAL CO., LTD. 510(k) NO: K162248(Traditional)
ATTN: Masaharu Aritomi PHONE NO : 81 3 32963727
1-105 KANDA JINBOCHO SE DECISION MADE: 03-MAY-17
Chiyoda-ku JP 101-8101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cedic Enteral ENFit Transition Connectors
CEDIC S.R.L. 510(k) NO: K162254(Traditional)
ATTN: TIZIANA MELIS PHONE NO : 39 02 55300174 110
VIA LIBERAZIONE, 63/9 SE DECISION MADE: 04-MAY-17
PESCHIERA BORROMEO IT 20068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite Rheumatoid Factor Kit
THE BINDING SITE GROUP LTD. 510(k) NO: K162263(Traditional)
ATTN: JON LAUDER PHONE NO : 44 0121 4569500
8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 03-MAY-17
BIRMINGHAM GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Cranial Fusion System
LIFE SPINE INC. 510(k) NO: K162266(Traditional)
ATTN: RANDY LEWIS PHONE NO : 847 8846117
13951 S QUALITY DRIVE SE DECISION MADE: 01-MAY-17
HUNTLEY IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDAPT Sleeved Monolithic Revision Stems
SMITH & NEPHEW INC. 510(k) NO: K162303(Abbreviated)
ATTN: KIM PHAN PHONE NO : 901 8003175
7135 Goodlett Farms Parkway SE DECISION MADE: 01-MAY-17
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Winner Transfer Wheelchair
Winner SG Pte Ltd 510(k) NO: K162328(Traditional)
ATTN: Michael Pang PHONE NO : 65 9363 5453
14 Little Road #07-01 Tropical IndSE DECISION MADE: 11-MAY-17
Singapore SG 536987 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex Robotic System and Flex Colorectal Drive
Medrobotics Corporation 510(k) NO: K162330(Traditional)
ATTN: John D. Bonasera PHONE NO : 508 6926460
475 Paramount Drive SE DECISION MADE: 04-MAY-17
Raynham MD 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wondfo One Step Fecal Occult Blood (FOB) Test
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K162333(Traditional)
ATTN: Bin Chen PHONE NO : 86 20 32296069
WONDFO SCIENTECH PARK, SOUTH CHINASE DECISION MADE: 14-MAY-17
GUANGZHOU CN 510641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABCcolla Collagen Matrix
ACRO BIOMEDICAL CO., LTD 510(k) NO: K162348(Traditional)
ATTN: DAR-JEN HSIEH PHONE NO : 886 7 6955569
3F., NO.57, LUKE 2ND RD, LUJHU DISSE DECISION MADE: 10-MAY-17
Kaohsiung City TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREND PSA PLUS (reagent cartridge)
NANOENTEK USA INC 510(k) NO: K162378(Traditional)
ATTN: SUNMI HAN PHONE NO : 925 2250108
5627 STONERIDGE DRIVE SUITE 304 SE DECISION MADE: 17-MAY-17
PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Locking Plate System
BEIJING KEYI MEDICAL DEVICE TECHNO510(k) NO: K162380(Traditional)
ATTN: CINDY NIE PHONE NO : 86 10 67853877
BUILDING 1, NO. 11, 3RD JINGHAI STSE DECISION MADE: 02-MAY-17
BEIJING CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avazzia
AVAZZIA, INC. 510(k) NO: K162392(Traditional)
ATTN: TAMMY LAHUTSKY PHONE NO : 214 5752820
13140 COIT ROAD SUITE 515 SE DECISION MADE: 12-MAY-17
DALLAS TX 75240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gems Vitrification Set, Gems Warming Set
GENEA BIOMEDX PTY LTD 510(k) NO: K162409(Traditional)
ATTN: Kea Dent PHONE NO : 61 284 847677
LEVEL 2, 321 KENT STREET SE DECISION MADE: 24-MAY-17
SYDNEY AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GCE Zen-O Portable Oxygen Concentrator
OXUS, INC 510(k) NO: K162433(Traditional)
ATTN: RYAN LENARCIC PHONE NO : 248 7090490
2676 PALDAN SE DECISION MADE: 24-MAY-17
AUBURN HILLS MI 48326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
Cook Incorporated 510(k) NO: K162448(Traditional)
ATTN: Jessica Swafford PHONE NO : 812 3353575 104260
750 Daniels Way SE DECISION MADE: 26-MAY-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
ANGIODYNAMICS, INC 510(k) NO: K162449(Traditional)
ATTN: KASEY E NEWCOMB PHONE NO : 508 6587913
26 FOREST STREET SE DECISION MADE: 05-MAY-17
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matrix Data Management System
GLOBAL INSTRUMENTATION, LLC 510(k) NO: K162463(Traditional)
ATTN: JASON DEMASO PHONE NO : 315 6820272 116
8104 CAZENOVIA ROAD SE DECISION MADE: 24-MAY-17
MANLIUS NY 13104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foundation 3D Interbody
CoreLink, LLC 510(k) NO: K162496(Traditional)
ATTN: Stephan Jones PHONE NO : 888 3497808
7911 Forsyth Blvd, Suite # 200 SE DECISION MADE: 04-MAY-17
St. Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The IQool System
BRAIN COOL AB 510(k) NO: K162523(Traditional)
ATTN: MARTIN WALEIJ PHONE NO : 46 733 937076
SCHEELEVAGEN 2 MEDICON VILLAGE SE DECISION MADE: 03-MAY-17
MEDICON VILLAGE SE SE-223 81 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Creatine Kinase-MB
ROCHE DIAGNOSTICS 510(k) NO: K162526(Traditional)
ATTN: NOEL B. MENCIAS PHONE NO : 317 5213172
9115 HAGUE ROAD SE DECISION MADE: 26-MAY-17
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoMed PINNACLE Driver
OSTEOMED 510(k) NO: K162542(Traditional)
ATTN: KATHRYN A. JAYNE PHONE NO : 972 6774766
3885 ARAPAHO ROAD SE DECISION MADE: 19-MAY-17
ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIK Sterile Acupuncture Needles for Single Use
CHANGCHUN AIK MEDICAL DEVICES CO.,510(k) NO: K162566(Traditional)
ATTN: XINGWANG LI PHONE NO : 86 1336 4688867
NO. 25, KAREN INDUSTRIAL PARK, JIUSE DECISION MADE: 11-MAY-17
CHANGCHUN CN 130507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AmCAD-US
AmCad BioMed Corporation 510(k) NO: K162574(Traditional)
ATTN: Jack Yang PHONE NO : 866 2 27136227
FL.3, NO. 167, Fu Hsing N. RD. SE DECISION MADE: 30-MAY-17
Taipei TW 105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Craniomaxillofacial Distraction System (CMFD)
SYNTHES USA PRODUCTS, LLC 510(k) NO: K162594(Traditional)
ATTN: NICHOLAS FOUNTOULAKIS PHONE NO : 610 7196553
1301 GOSHEN PARKWAY SE DECISION MADE: 08-MAY-17
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAPI Seal
BISCO, INC. 510(k) NO: K162598(Traditional)
ATTN: Ryan Hobson PHONE NO : 847 5346143
1100 WEST IRVING PARK RD. SE DECISION MADE: 23-MAY-17
SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infusion Set for Single Use
SHINVA ANDE HEALTHCARE APPARATUS C510(k) NO: K162601(Traditional)
ATTN: Xiaolei Tian PHONE NO : 86 533 3917821
NO.77 DEVELOPMENT ZONE NORTH RD SE DECISION MADE: 31-MAY-17
Zibo CN 255086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo O3 Regional Oximeter System
MASIMO CORPORATION 510(k) NO: K162603(Traditional)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 2977683
52 DISCOVERY SE DECISION MADE: 26-MAY-17
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remel Spectra ESBL
REMEL, INC. 510(k) NO: K162620(Traditional)
ATTN: CYNTHIA KNAPP PHONE NO : 800 8718909 332
12076 SANTA FE DRIVE SE DECISION MADE: 01-MAY-17
LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive NuvaLine Mobile App
NUVASIVE, INCORPORATED 510(k) NO: K162647(Traditional)
ATTN: Olga Lewis PHONE NO : 858 3204588
7475 LUSK BLVD. SE DECISION MADE: 01-MAY-17
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kitazato IUI Catheter
Kitazato Corporation 510(k) NO: K162667(Traditional)
ATTN: Mari Yazaki PHONE NO : 81 3 58006055
1-1-8 Shibadaimon, Minato-ku SE DECISION MADE: 11-MAY-17
Tokyo JP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SL 220
Carl Zeiss Meditec AG 510(k) NO: K162684(Traditional)
ATTN: Christian Muenster PHONE NO : 49 3641 220301
SE DECISION MADE: 31-MAY-17
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: bibag
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K162716(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 WINTER STREET SE DECISION MADE: 18-MAY-17
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CreoDent Solidex Customized Abutment
CreoDent Prosthetics, Ltd. 510(k) NO: K162734(Traditional)
ATTN: Calvin Shim PHONE NO : 212 3023860
29 West 30th Street 11th Floor SE DECISION MADE: 08-MAY-17
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
Surgical Instrument Services and S510(k) NO: K162751(Traditional)
ATTN: Brandi J Panteleon PHONE NO : 541 9233310
2747 SW 6th St. SE DECISION MADE: 01-MAY-17
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHAKOS Disposable Retinal Cryo Probe
PHAKOS 510(k) NO: K162756(Traditional)
ATTN: OLIVER AUMAITRE PHONE NO : 33 4 9887400
62 RUE KLEBER SE DECISION MADE: 03-MAY-17
MONTREUIL FR 93100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIVATE™ Compression Screws
GLOBUS MEDICAL, INC. 510(k) NO: K162825(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 01-MAY-17
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. Mobility Scooter
CHIEN TI ENTERPRISE CO., LTD. 510(k) NO: K162952(Traditional)
ATTN: VIVIAN LO PHONE NO : 886 229 032987
NO. 13, LANE 227, FU YING RD SE DECISION MADE: 03-MAY-17
NEW TAIPEI CITY, HSIN CHUANG DISTR510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kangaroo Feeding Tube with IRIS Technology
Covidien (dba Medtronic) 510(k) NO: K163002(Traditional)
ATTN: Alexis Erazo PHONE NO : 508 4524673
15 Hampshire St SE DECISION MADE: 16-MAY-17
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Software
ETIOMETRY, INC. 510(k) NO: K163065(Traditional)
ATTN: DIMITAR BARONOV PHONE NO : 857 3669333
119 BRAINTREE STREET SUITE 210 SE DECISION MADE: 26-MAY-17
BOSTON MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kent Camera
KENT IMAGING INC. 510(k) NO: K163070(Traditional)
ATTN: Darrell Barnhart PHONE NO : 403 4557610
1440, 720- 13TH AVENUE SW SE DECISION MADE: 05-MAY-17
CALGARY CA T2R 1M5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: vascuCAP
Elucid Bioimaging, Inc. 510(k) NO: K163071(Traditional)
ATTN: Andrew J. Buckler PHONE NO : 978 4680508
225 Main Street Suite 15 SE DECISION MADE: 24-MAY-17
Wenham MA 01984 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
Sol-Millennium Medical, Inc. 510(k) NO: K163073(Traditional)
ATTN: Jim Barley PHONE NO : 404 9732200
1735 North Brown Road, Suite 120 SE DECISION MADE: 19-MAY-17
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma Edge System
Chirurgie Innovation 510(k) NO: K163090(Third Party - Traditional)
ATTN: Guillaume Noury PHONE NO : 33 616 166330
27 PLACE VICTOR SCHOELCHER SE DECISION MADE: 23-MAY-17
MASSY FR F-91300 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TinniLogic Mobile Tinnitus Management Device
JIANGSU BETTERLIFE MEDICAL CO., LT510(k) NO: K163094(Traditional)
ATTN: HONGWEI XU PHONE NO : 86 512 52269378
NO.11 SI HAI ROAD, CHANGSHU ECONOMSE DECISION MADE: 17-MAY-17
CHANGSHU CN 215513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alpha Pure
KOROAD AMERICA 510(k) NO: K163117(Traditional)
ATTN: YEON JAE LEE PHONE NO : 714 2136910
895 DOVE ST, SUITE 300 SE DECISION MADE: 09-MAY-17
NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviSuite SSI Edition
MEDCOM GMBH 510(k) NO: K163119(Traditional)
ATTN: JOHANNES MESSOW PHONE NO : 49 615 195147258
RUNDETURMSTR. 50 SE DECISION MADE: 01-MAY-17
DARMSTADT DE 64283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-dec NLZ Electric Motor System
NAKANISHI, INC. 510(k) NO: K163131(Traditional)
ATTN: KIMIHIKO SATOH PHONE NO : 81 289 644325
700 SHIMOHINATA SE DECISION MADE: 11-MAY-17
KANUMA-SHI JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
GEMSS MEDICAL SYSTEMS CO., LTD 510(k) NO: K163140(Traditional)
ATTN: Sang Woo Lee PHONE NO : 82 31 7647321
2nd Floor, 29, Dunchon-daero 541 bSE DECISION MADE: 26-MAY-17
Seongnam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
SMITHS MEDICAL ASD, INC. 510(k) NO: K163172(Traditional)
ATTN: Bruce Backlund PHONE NO : 763 3833265
6000 NATHAN LANE N SE DECISION MADE: 24-MAY-17
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSLACE™ Spinal Tethering System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K163181(Traditional)
ATTN: Becky Ronner PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 16-MAY-17
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTION II Laser System
LUTRONIC CORPORATION 510(k) NO: K163196(Traditional)
ATTN: Jhung Won Vojir PHONE NO : 82 31 9083440
219, SOWON-RO, HAENGSIN-DONG SE DECISION MADE: 24-MAY-17
DEOGYANG-GU, GOYANG-SI KR 410-722510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook Holmium Laser Fiber
COOK INCORPORATED 510(k) NO: K163197(Traditional)
ATTN: Colin Jacob PHONE NO : 812 3353575 104965
750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 24-MAY-17
BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A08 Power wheelchair
Kunshan Aoshida Electric Technolog510(k) NO: K163204(Traditional)
ATTN: Shen Wenhua PHONE NO : 86 512 57816288
No. 65, Matang Road SE DECISION MADE: 05-MAY-17
Kunshan CN 215300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIC Extremely Small Staple
Epic Extremely, LLC 510(k) NO: K163226(Traditional)
ATTN: Dan Schwartzbauer PHONE NO : 412 9560302
120 Marguerite Dr, Ste 301 SE DECISION MADE: 16-MAY-17
Cranberry Twp PA 16066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Kiss Zirconia
AMS 510(k) NO: K163238(Traditional)
ATTN: HYUNA KIM PHONE NO : 82 708 7182828
#530 NA-DONG MACHZONE, 117, HWANGGSE DECISION MADE: 04-MAY-17
GYEONGGI-DO KR 10048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: truFreeze System
CSA MEDICAL, INC. 510(k) NO: K163244(Traditional)
ATTN: Sherrie Coval-Goldsmith PHONE NO : 781 5384720
91 HARTWELL AVENUE SE DECISION MADE: 24-MAY-17
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longitudinal Brain Imaging (LoBI) application
Philips Medical Systems Nederland 510(k) NO: K163250(Traditional)
ATTN: Yoram Levy PHONE NO : 1 800 7229377
Veenpluis 4-6 5684 PC Best SE DECISION MADE: 11-MAY-17
Best Noord-Brabant NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitreOx Anti-fog Solution
SiO2 Nanotech, LLC 510(k) NO: K163257(Traditional)
ATTN: CLARIZZA WATSON PHONE NO : 602 5653447
275 N. GATEWAY DRIVE SUITE 126 SE DECISION MADE: 24-MAY-17
PHOENIX AZ 85034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
ATRICURE INC. 510(k) NO: K163261(Traditional)
ATTN: Jonathan McElwee PHONE NO : 513 6444249
7555 Innovation Way SE DECISION MADE: 19-MAY-17
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ANDON HEALTH CO.,LTD 510(k) NO: K163276(Abbreviated)
ATTN: LIU YI PHONE NO : 86 22 60526161 9060
NO 3, JIN PING ST, YA AN RD NANKASE DECISION MADE: 11-MAY-17
TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Colink™ Plating System
IN2BONESUSA, LLC 510(k) NO: K163293(Traditional)
ATTN: JOE CLIFT PHONE NO : 901 2607931
6060 POPLAR AVE SUITE 380 SE DECISION MADE: 05-MAY-17
MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Internal Distraction - Sterile
KLS Martin LP 510(k) NO: K163315(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 05-MAY-17
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precifit Medical Kirschner Wires
PRECIFIT MEDICAL LTD 510(k) NO: K163327(Traditional)
ATTN: ZHEN YU(ERIC) WU PHONE NO :
951 AVIATION PKWY STE 100 SE DECISION MADE: 08-MAY-17
MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS V3 Conical Connection Dental Implant System
MIS Implants Technologies Ltd. 510(k) NO: K163349(Traditional)
ATTN: Arbel Shezaf PHONE NO : 972 4 9016800
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 26-MAY-17
Bar Lev Industrial Park IL 201560510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter
ANGIODYNAMICS, INC. 510(k) NO: K163356(Traditional)
ATTN: ROBIN FULLER PHONE NO : 508 6587986
26 FOREST STREET SE DECISION MADE: 30-MAY-17
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
PHADIA AB 510(k) NO: K163370(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 05-MAY-17
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxitone 1000
Oxitone Medical Ltd. 510(k) NO: K163382(Traditional)
ATTN: Leon Eisen PHONE NO : 972 9 8346731
17 Atir Yeda Street SE DECISION MADE: 09-MAY-17
Kfar Saba IL 4464312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hybrid3D
Hermes Medical Solutions AB 510(k) NO: K163394(Traditional)
ATTN: Joakim Arwidson PHONE NO : 46 8 190325
Skeppsbron 44 SE DECISION MADE: 22-MAY-17
Stockholm SE 11130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prontosan Wound Gel
B. Braun Medical, Inc. 510(k) NO: K163430(Traditional)
ATTN: Nancy Skocypec PHONE NO : 610 5962796
901 Marcon Boulevard SE DECISION MADE: 23-MAY-17
Allentown PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
Cook Ireland Ltd. 510(k) NO: K163468(Traditional)
ATTN: Jacinta Kilmartin PHONE NO : 011 353 61239483
O'Halloran Road, National TechnoloSE DECISION MADE: 04-MAY-17
Limerick IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lubricity
You First Services, Incorporated 510(k) NO: K163476(Traditional)
ATTN: Jeffrey Eberhard PHONE NO : 716 2047215
1576 Sweet Home Road SE DECISION MADE: 10-MAY-17
Amherst NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical 510(k) NO: K163481(Traditional)
ATTN: Troy Taylor PHONE NO : 760 8148047
5670 El Camino Real Suite B SE DECISION MADE: 03-MAY-17
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthodontic Acrylic 2
Lang Dental Manufacturing Co., Inc510(k) NO: K163482(Traditional)
ATTN: Dave Lang PHONE NO : 847 2156622
175 Messner Drive PO Box 969 SE DECISION MADE: 31-MAY-17
Wheeling IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSR'obot Biopsy Kit
Biobot Surgical Pte Ltd 510(k) NO: K163502(Traditional)
ATTN: Lai Chee LIEW PHONE NO : 65 6351 1868
79, Ayer Rajah Crescent, #04-05/06SE DECISION MADE: 16-MAY-17
Singapore SG 139955 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIETTA PRECISION
HITACHI, LTD 510(k) NO: K163505(Traditional)
ATTN: ANGELA VAN ARSDALE PHONE NO : 203 2695088 346
10 FAIRFIELD BOULEVARD SE DECISION MADE: 30-MAY-17
WALLINGFORD CT 06492-5903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrisMax Control Unit
BAXTER HEALTHCARE CORP 510(k) NO: K163530(Traditional)
ATTN: Chris Scavotto PHONE NO : 763 4634621
7601 Northland Drive Suite 170 SE DECISION MADE: 03-MAY-17
Brooklyn Park MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue
HEBEI TITANS MEDICAL SUPPLY TECHNO510(k) NO: K163553(Traditional)
ATTN: Shaozhang Nan PHONE NO : 86 319 7295820
EAST OF JINGQIANG COMMUNITY, DAQINSE DECISION MADE: 22-MAY-17
NANGONG CN 051800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SS SA Fixture
OSSTEM IMPLANT Co., Ltd. 510(k) NO: K163557(Traditional)
ATTN: Mr. HeeKwon PHONE NO : 82 51 8502575
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 15-MAY-17
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIT LAMP SL-2000
NIDEK CO., LTD. 510(k) NO: K163564(Traditional)
ATTN: Yoneji Mizuno PHONE NO : 81 533 678901
34-14 Maehama, Hiroishicho SE DECISION MADE: 19-MAY-17
Gamagori JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE SYNECOR Preperitoneal Biomaterial
W. L. Gore & Associates, Inc. 510(k) NO: K163576(Traditional)
ATTN: Michael J. Titus PHONE NO : 410 5068316
1505 N. Fourth Street SE DECISION MADE: 11-MAY-17
Flagstaff AZ 86004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Blood Pressure Monitor-Automatic Upper Arm Style
Shenzhen Combei Technology CO., LT510(k) NO: K163606(Traditional)
ATTN: Huaguang Meng PHONE NO : 86 0755 2958896
Floor 5, Block B, Building G, JinxSE DECISION MADE: 09-MAY-17
Guanlan, Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOTOME M+, PIEZOTOME M+ Handpiece
SATALEC-ACTEON GROUP 510(k) NO: K163610(Traditional)
ATTN: PHILIPPE GIRARD PHONE NO : 11 335 56340607
17 AVENUE GUSTAVE EIFFEL SE DECISION MADE: 19-MAY-17
MERIGNAC FR 33708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
CareFusion 2200 Inc 510(k) NO: K163615(Traditional)
ATTN: Jane Weber PHONE NO : 847 3628094
75 North Fairway Drive SE DECISION MADE: 04-MAY-17
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDIGO Aspiration System
PENUMBRA, INC. 510(k) NO: K163618(Traditional)
ATTN: RICHARD KIMURA PHONE NO : 510 9952034
ONE PENUMBRA PLACE SE DECISION MADE: 24-MAY-17
ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitoss Bioactive (BA) Injectable
Orthovita, Inc. 510(k) NO: K163621(Traditional)
ATTN: John Rossman PHONE NO : 610 6401775
45 Great Valley Parkway SE DECISION MADE: 02-MAY-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lung Vision
BODY VISION MEDICAL LTD. 510(k) NO: K163622(Traditional)
ATTN: DORIAN AVERBUCH PHONE NO : 646 8637848
34 SOKOLOV ST. SE DECISION MADE: 11-MAY-17
RAMAT HASHARON IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Luminex Corporation 510(k) NO: K163626(Traditional)
ATTN: Kate Linak PHONE NO : 608 2038909
12212 Technology Blvd SE DECISION MADE: 02-MAY-17
Austin TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental 5 Multi Diode laser
BIO-MED USA INC 510(k) NO: K163638(Traditional)
ATTN: YOUNG CHI PHONE NO : 1 973 2785222
111 ELLISON STREET SE DECISION MADE: 15-MAY-17
PATERSON NJ 07505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QZA and RS Dental Implant Systems
TRINON Titanium GmbH 510(k) NO: K163640(Abbreviated)
ATTN: Katja Lvova PHONE NO : 49 72 1932700
Augartenstr. 1 SE DECISION MADE: 03-MAY-17
Karlsruhe DE 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden QP-160AK EEG Trend Program
Nihon Kohden Corporation 510(k) NO: K163644(Traditional)
ATTN: Tom Bento PHONE NO : 949 6809048
1-31-4 Nishiochiai, Shinjuku-Ku SE DECISION MADE: 19-MAY-17
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K163658(Traditional)
ATTN: Darius Daruwala PHONE NO : 914 5242812
511 Benedict Avenue SE DECISION MADE: 23-MAY-17
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRx plus
Zephyr Sleep Technologies 510(k) NO: K163665(Traditional)
ATTN: Sabina Bruehlmann PHONE NO : 1 877 3418814
610A 70 Ave SE SE DECISION MADE: 05-MAY-17
Calgary CA T2H-2J6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humeris Shoulder
Fx Solutions 510(k) NO: K163669(Traditional)
ATTN: Jean-Jacques Martin PHONE NO : 33 4 74553555
1663 Rue de Majornas SE DECISION MADE: 17-MAY-17
Viriat FR 01440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart One Lumbar Interbody Fusion Device
SPINEOLOGY INC. 510(k) NO: K163670(Traditional)
ATTN: Jacqueline A. Hauge PHONE NO : 651 2568500
7800 3RD STREET N., SUITE 600 SE DECISION MADE: 08-MAY-17
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
NANOVA BIOMATERIALS, INC. 510(k) NO: K163672(Traditional)
ATTN: ANDREW RITTS PHONE NO : 573 8756682
3806 MOJAVE CT SE DECISION MADE: 05-MAY-17
COLUMBIA MO 65202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortilink™-C with TETRAfuse™ 3D Technology
RTI Surgical, Inc. 510(k) NO: K163673(Traditional)
ATTN: Diana Taylor PHONE NO : 386 4188888 4384
11621 Research Circle SE DECISION MADE: 23-MAY-17
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
A&D COMPANY, LTD 510(k) NO: K163683(Special)
ATTN: JERRY WANG PHONE NO : 408 5185113
1756 AUTOMATION PARKWAY SE DECISION MADE: 03-MAY-17
SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Direxion and Direxion HI-FLO Torqueable Microcatheters
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K163701(Special)
ATTN: LIZ JOHNSTON PHONE NO : 763 4941676
THREE SCIMED PLACE SE DECISION MADE: 16-MAY-17
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K163702(Traditional)
ATTN: PAUL BIGGINS PHONE NO : 714 6697808
1385 SHIMOISHIGAMI SE DECISION MADE: 30-MAY-17
OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive CoRoent Ti-C System
NuVasive, Incorporated 510(k) NO: K163707(Traditional)
ATTN: Cynthia Adams PHONE NO : 858 3204549
7475 Lusk Blvd. SE DECISION MADE: 01-MAY-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc. 510(k) NO: K170007(Traditional)
ATTN: James A. Bonafini PHONE NO : 585 4589409
1667 Lake Avenue, Suite 354 SE DECISION MADE: 31-MAY-17
Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation S8 Spine Software v1.0.0
MEDTRONIC NAVIGATION 510(k) NO: K170011(Traditional)
ATTN: JOHN CONNOR PHONE NO : 720 8902311
826 COAL CREEK CIRCLE SE DECISION MADE: 01-MAY-17
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStationTM S8 ENT Software
Medtronic Navigation, Inc. 510(k) NO: K170018(Traditional)
ATTN: K. Elizabeth Waite PHONE NO : 720 8903200
826 Coal Creek Circle SE DECISION MADE: 19-MAY-17
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMV Scientific Cannulated Screws
SMV Scientific 510(k) NO: K170021(Traditional)
ATTN: Nephi Zufelt PHONE NO : 512 7508622
111 Sandra Muraida Way Unit 18A SE DECISION MADE: 22-MAY-17
Austin TX 78703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPiN Thoracic Navigation System
Veran Medical Technologies, Inc. 510(k) NO: K170023(Traditional)
ATTN: Scott Wrightstone PHONE NO : 314 6598500
1908 Innerbelt Business Center Dr SE DECISION MADE: 15-MAY-17
St. Louis MO 63114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AssureTech Panel Dip Test, AssureTech Quick Cup Test
ASSURE TECH (HANGZHOU) CO., LTD. 510(k) NO: K170049(Traditional)
ATTN: SHISHENG LING PHONE NO : 86 571 88868960
NO.10, XIYUANSAN RD. WESTLAKE ECONSE DECISION MADE: 02-MAY-17
HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Softcure 96
WELLRAY MEDICAL LASER, INC. 510(k) NO: K170068(Traditional)
ATTN: Richard O DeRoberts PHONE NO : 304 8744209
216 Moores Run Rd. SE DECISION MADE: 05-MAY-17
Wardensville WV 26851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
MEDISONO, LLC 510(k) NO: K170078(Abbreviated)
ATTN: JORGE MILLAN PHONE NO : 786 4165587
3511 SILVERSIDE RD STE 105 SE DECISION MADE: 17-MAY-17
WILMINGTON DE 19810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Test of Variables of Attention (T.O.V.A.) Version 9.0
THE TOVA COMPANY 510(k) NO: K170082(Traditional)
ATTN: CHRIS HOLDER PHONE NO : 360 6612899
2828 SW CORBETT AVE SUITE 128 SE DECISION MADE: 17-MAY-17
PORTLAND OR 97201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcceleDent Optima
OrthoAccel Technology Inc. 510(k) NO: K170093(Traditional)
ATTN: Jouana Harris-Livings PHONE NO : 832 7694632
6575 West Loop South, Suite 200 SE DECISION MADE: 26-MAY-17
Bellaire TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgi Max Ultra
elliquence, LLC 510(k) NO: K170107(Traditional)
ATTN: Paul D. Buhrke IV PHONE NO : 516 2779010
2455 Grand Avenue SE DECISION MADE: 03-MAY-17
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xultan 5.5 Pedicle Screw System
Met One Technologies 510(k) NO: K170108(Traditional)
ATTN: Dan Gerbec PHONE NO : 915 3010834
154 N. Festival Dr., Ste. F SE DECISION MADE: 02-MAY-17
El Paso TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
Pulsaderm LLC 510(k) NO: K170111(Traditional)
ATTN: Gloria Avendano PHONE NO : 239 2087541
12801 COMMONWEALTH DR. UNITS 2-6 SE DECISION MADE: 08-MAY-17
Fort Myers FL 33913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagVita TMS Therapy - w/MagPro R20
TONICA ELEKTRONIK A/S 510(k) NO: K170114(Traditional)
ATTN: LISE TERKELSEN PHONE NO : 45 44 998444
LUCERNEMARKEN 15 SE DECISION MADE: 01-MAY-17
FARUM DK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Lumenis Ltd. 510(k) NO: K170121(Special)
ATTN: Yehudit Kraizer PHONE NO : 972 54 9599172
Yokneam Industrial Park, 6 HakidmaSE DECISION MADE: 22-MAY-17
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FFR V2.5
Philips Volcano 510(k) NO: K170133(Traditional)
ATTN: Elaine Alan PHONE NO : 858 7641281
3721 Valley Ctr. Dr. SE DECISION MADE: 26-MAY-17
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREFOIL System
Nobel Biocare AB 510(k) NO: K170135(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 11-MAY-17
Goteberg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
Stimwave Technologies Incorporated510(k) NO: K170141(Traditional)
ATTN: Elizabeth Greene PHONE NO : 800 9655134
901 East Las Olas Boulevard, SuiteSE DECISION MADE: 02-MAY-17
Fort Lauderdale FL 33301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
HARTALEGA SDN BHD 510(k) NO: K170152(Traditional)
ATTN: KUAN KAM HON PHONE NO : 603 62771733
DATARAN SD PJU 9 SE DECISION MADE: 05-MAY-17
BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT
DEVICE: UNiD Spine Analyzer
MEDICREA INTERNATIONAL 510(k) NO: K170172(Traditional)
ATTN: David Ryan PHONE NO : 00 33 472018787
5389 Route de Strasbourg-Vancia SE DECISION MADE: 24-MAY-17
Rillieux La Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultravision Visual Field Clearing System
Alesi Surgical Ltd. 510(k) NO: K170178(Traditional)
ATTN: DAVID BRODERICK PHONE NO : 44 02920 1022
Cardiff MediCentre, Heath Park SE DECISION MADE: 26-MAY-17
Cardiff GB CF14 4UJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Will3D
HDX WILL CORP. 510(k) NO: K170180(Traditional)
ATTN: Seung-Il Chun PHONE NO : 82 43 7107318
#105, 201, 202, 203, 204, 38, OsonSE DECISION MADE: 08-MAY-17
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuantX
Quantitative Insights, Inc. 510(k) NO: K170195(Traditional)
ATTN: Robert Tomek PHONE NO : 773 9604670
1452 E 53rd St. SE DECISION MADE: 17-MAY-17
Chicago IL 60615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
A&D Company, Ltd. 510(k) NO: K170196(Special)
ATTN: Jerry Wang PHONE NO : 408 5185113
1756 Automation Parkway SE DECISION MADE: 17-MAY-17
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unity Network ID
GE Healthcare 510(k) NO: K170199(Special)
ATTN: Robert Casarsa PHONE NO : 414 3623063
8200 West Tower Ave. SE DECISION MADE: 12-MAY-17
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
Shenzhen Kentro Medical Electronic510(k) NO: K170205(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755 33825998
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 11-MAY-17
Shenzhen City CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexitouch System
Tactile Systems Technology, Inc (d510(k) NO: K170216(Traditional)
ATTN: Thomas A. Dold PHONE NO : 612 3555100
1331 Tyler Street NE, Suite 200 SE DECISION MADE: 26-MAY-17
Minneapolis MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belimed Steam Sterilizer MST-H TOP 5000
Belimed AG 510(k) NO: K170228(Abbreviated)
ATTN: Christoph Hermens PHONE NO : 41 41 4497888
Grienbachstrasse 11 SE DECISION MADE: 12-MAY-17
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiGen™ 2 RF Generator System
STRYKER CORPORATION 510(k) NO: K170242(Traditional)
ATTN: BECKY DITTY PHONE NO : 269 3893434
4100 E. MILHAM AVE SE DECISION MADE: 25-MAY-17
KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSM Biomedical Dental Bone Graft
Kensey Nash Corporation dba DSM Bi510(k) NO: K170245(Traditional)
ATTN: Susan Pileggi PHONE NO : 484 7132100
735 Pennsylvania Drive SE DECISION MADE: 16-MAY-17
Exton PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS
TRUABUTMENT 510(k) NO: K170259(Traditional)
ATTN: BRANDON KIM PHONE NO : 714 9561488
300 SOUTH HARBOR BLVD #520 SE DECISION MADE: 25-MAY-17
ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hee HR Mini
Oriental Inspiration Limited 510(k) NO: K170269(Traditional)
ATTN: Andy Wu PHONE NO : 852 2687 3496
Unit 607, The Lakeside 2, West WinSE DECISION MADE: 03-MAY-17
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
C.R. BARD INC. 510(k) NO: K170278(Traditional)
ATTN: KATHERINE EARLE PHONE NO : 401 8258450
100 CROSSINGS BOULEVARD SE DECISION MADE: 31-MAY-17
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew VISIONAIRE Adaptive Guides
Smith & Nephew, Inc 510(k) NO: K170282(Traditional)
ATTN: Brad Sheals PHONE NO : 901 3996897
7135 Goodlett Farms Parkway SE DECISION MADE: 22-MAY-17
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Implants OKTAGON Bone Level Tapered Design
Hager& Meisinger GmbH 510(k) NO: K170287(Traditional)
ATTN: Melanie May PHONE NO : 0049 2131 2012292
Hansemannstrasse 10 SE DECISION MADE: 24-MAY-17
Neuss DE 41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
Shen Wei USA Inc. 510(k) NO: K170290(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave. Suite 102 SE DECISION MADE: 24-MAY-17
Union City CA 94587 510(k) STATEMENT
DEVICE: IontoDC
SOTERIX MEDICAL,INC. 510(k) NO: K170291(Traditional)
ATTN: ABHISHEK DATTA PHONE NO : 888 9908327
237 W 35 ST, 1401 SE DECISION MADE: 01-MAY-17
NEW YORK NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval
CR BARD 510(k) NO: K170294(Traditional)
ATTN: CHRISTINE LLOYD PHONE NO : 401 8258447
100 CROSSING BLVD SE DECISION MADE: 01-MAY-17
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E5 Series Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP. 510(k) NO: K170303(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f, yizhe bSE DECISION MADE: 19-MAY-17
shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERGRAFT BG Putty Bone Graft Substitute
Prosidyan, Inc 510(k) NO: K170306(Traditional)
ATTN: Charanpreet S. Bagga PHONE NO : 908 5173666
30 Technology Drive SE DECISION MADE: 24-MAY-17
Warren NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Extended Enteric Bacterial Panel, BD MAX System
BECTON, DICKINSON AND COMPANY 510(k) NO: K170308(Traditional)
ATTN: LAURA STEWART PHONE NO : 410 3164435
7 LOVETON CIRCLE SE DECISION MADE: 02-MAY-17
SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K170312(Traditional)
ATTN: DEEP PAL PHONE NO : 817 7886400
4620 NORTH BEACH ST SE DECISION MADE: 15-MAY-17
FORT WORTH TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalys Precision Laser System
Abbott Medical Optics Inc. 510(k) NO: K170322(Traditional)
ATTN: Audrey Munnerlyn PHONE NO : 408 2734106
510 Cottonwood Drive SE DECISION MADE: 19-MAY-17
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
RevMedx, Inc. 510(k) NO: K170334(Traditional)
ATTN: Amy K. Pointer PHONE NO : 503 2182172
25999 SW Canyon Creek Road, Suite SE DECISION MADE: 01-MAY-17
Wilsonville OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-View
Stroke2Prevent B.V. 510(k) NO: K170338(Traditional)
ATTN: Maarten Nibbelke PHONE NO : 31 038 3032630
Dokter Stolteweg 70 SE DECISION MADE: 16-MAY-17
8025 AZ Zwolle NL 8025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ocata Anterior Cervical System
Kalitec Direct, LLC 510(k) NO: K170342(Traditional)
ATTN: Scott Winn PHONE NO : 407 5452063
618 E. South Street Suite 500 SE DECISION MADE: 09-MAY-17
Orlando FL 32801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RA-308 Excimer Laser System, Excimer Laser Catheter
Ra Medical Systems, Inc. 510(k) NO: K170349(Traditional)
ATTN: Dean Irwin PHONE NO : 877 6351800
1930 Kellogg Ave. SE DECISION MADE: 24-MAY-17
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIO
Blue Belt Technologies, Inc. 510(k) NO: K170360(Traditional)
ATTN: Richard G. Confer PHONE NO : 763 4524950
2905 Northwest Blvd. Ste. 40 SE DECISION MADE: 02-MAY-17
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Pocket EEG Device
Ceribell, Inc. 510(k) NO: K170363(Traditional)
ATTN: Josef Parvizi PHONE NO : 650 5217003
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 08-MAY-17
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collagen Meniscus Implant XL
Ivy Sports Medicine, LLC 510(k) NO: K170364(Traditional)
ATTN: John Dichiara PHONE NO : 650 5620800
545 Penobscot Drive SE DECISION MADE: 02-MAY-17
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASHAPE POWER SYSTEM
Syneron Medical Ltd. 510(k) NO: K170370(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 73 2442200
Tavor Building, Industrial Zone, PSE DECISION MADE: 15-MAY-17
Yokneam Illit IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression Screws
Arthrex Inc. 510(k) NO: K170382(Special)
ATTN: David L. Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 11-MAY-17
Naples FL 34108-5553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
Zibo Chengxun Automatic Device Co.510(k) NO: K170393(Traditional)
ATTN: Ding Wei PHONE NO : 86 533 2341615
No. 37 Minan Road, High-tech IndusSE DECISION MADE: 09-MAY-17
Zibo CN 255088 510(k) STATEMENT
DEVICE: Piccolo Composite® Plate System
CarboFix Orthopedics Ltd. 510(k) NO: K170401(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 12-MAY-17
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
Bio-Rad Laboratories 510(k) NO: K170413(Traditional)
ATTN: Juang Wang PHONE NO : 510 7414609
5500 E. 2nd Street SE DECISION MADE: 11-MAY-17
Benicia CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiCase Viewer
Materialise NV 510(k) NO: K170419(Traditional)
ATTN: Oliver Clemens PHONE NO : 32 163 96280
Technologielaan 15 SE DECISION MADE: 11-MAY-17
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KISSloc Suture System
Arthrosurface, Inc 510(k) NO: K170440(Traditional)
ATTN: Dawn J. Wilson PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 03-MAY-17
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LT-300 SD Digital Video Colposcope
Lutech Industries, Inc. 510(k) NO: K170446(Traditional)
ATTN: Leanna Vachula PHONE NO : 631 5846688
105 Remington Blvd Suite C SE DECISION MADE: 21-MAY-17
Ronkonkoma NY 11779 510(k) STATEMENT
DEVICE: KARL STORZ ShuntScope
KARL STORZ Endoscopy-America, Inc.510(k) NO: K170462(Traditional)
ATTN: Susie S. Chen PHONE NO : 424 2188201
2151 E. Grand Avenue SE DECISION MADE: 16-MAY-17
EI Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NxStage System One Plus
NxStage Medical, Inc 510(k) NO: K170469(Traditional)
ATTN: Randall Covill PHONE NO : 978 2984163
350 Merrimack Street SE DECISION MADE: 09-MAY-17
Lawrence MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICAGE™ System
Sicage LLc 510(k) NO: K170475(Traditional)
ATTN: Kristi Vondra PHONE NO : 605 2716103
6709 S. Minnesota Ave, Suite 206 SE DECISION MADE: 05-MAY-17
Souix Falls SD 57108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strep B Carrot Broth Kit
Hardy Diagnostics 510(k) NO: K170481(Traditional)
ATTN: Rianna Malherbe PHONE NO : 805 3462766
1430 West McCoy Lane SE DECISION MADE: 16-MAY-17
Santa Maria CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHTONG II PICC Catheter
L&Z US, Inc. 510(k) NO: K170486(Special)
ATTN: Jenella Coutts PHONE NO : 718 6010889 1
6 Horizon Road SE DECISION MADE: 25-MAY-17
Fort Lee NJ 07024 510(k) STATEMENT
DEVICE: Skylit Phototherapy System
Skylit Medical 510(k) NO: K170489(Traditional)
ATTN: Martyn Gross PHONE NO : 858 3484959
4225 Executive Square, Suite 420 SE DECISION MADE: 23-MAY-17
La Jolla CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solana C. difficile Assay
Quidel Corporation 510(k) NO: K170491(Traditional)
ATTN: Ronald H. Lollar PHONE NO : 740 5893373
2005 East State Street, Suite 100 SE DECISION MADE: 11-MAY-17
Athens OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
Stryker Corporation 510(k) NO: K170496(Traditional)
ATTN: Meriam Gabera PHONE NO : 201 7608043
2 Pearl Court SE DECISION MADE: 16-MAY-17
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROLaser Advance+
Dentsply Sirona 510(k) NO: K170500(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 16-MAY-17
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
Bio-Rad Laboratories 510(k) NO: K170509(Traditional)
ATTN: Arlene Carillo PHONE NO : 510 7414613
5500 East Second Street SE DECISION MADE: 19-MAY-17
Benicia CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Central Monitoring System
Guangdong Biolight Meditech Co., L510(k) NO: K170514(Traditional)
ATTN: Jin Liang PHONE NO : 86 756 3399967
No.2 Innovation First Road, TechniSE DECISION MADE: 24-MAY-17
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINITY/3D PROSTATE SUITE
KOELIS 510(k) NO: K170521(Traditional)
ATTN: Laetitia GERVAIS PHONE NO : 33 458 176810
16, chemin du vieux chene SE DECISION MADE: 30-MAY-17
MEYLAN FR 38240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIPER PRIME™ Screws with Fenestrations
Medos International, SARL 510(k) NO: K170543(Traditional)
ATTN: Karen Sylvia PHONE NO : 508 9773804
Chemin-Blanc 38 SE DECISION MADE: 04-MAY-17
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GenePOC GBS LB
GenePOC Inc. 510(k) NO: K170557(Traditional)
ATTN: Guy Sevigny PHONE NO : 1 418 6503535
360 rue Franquet SE DECISION MADE: 25-MAY-17
Quebec CA G1P 4N3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: revogene
GenePOC Inc. 510(k) NO: K170558(Traditional)
ATTN: Guy Sevigny PHONE NO : 1 418 6503535
360 rue Franquet SE DECISION MADE: 25-MAY-17
Quebec CA G1P 4N3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empowr CR Knee Tibial Insert
Encore Medical, L.P. 510(k) NO: K170573(Traditional)
ATTN: Desiree Wells PHONE NO : 512 8346302
9800 Metric Blvd. SE DECISION MADE: 31-MAY-17
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
Ever Global (Vietnam) Enterprise C510(k) NO: K170575(Abbreviated)
ATTN: Jerry Lin PHONE NO : 84 613 514022
Long Thanh Industrial Zone Taman VSE DECISION MADE: 16-MAY-17
Dong Nai Province VN 810000 510(k) STATEMENT
DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
LENSAR, Inc. 510(k) NO: K170576(Traditional)
ATTN: Keith Peck PHONE NO : 888 5756412
2800 Discovery Drive, Suite 100 SE DECISION MADE: 05-MAY-17
ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Total Knee Application
MAKO Surgical Corp. 510(k) NO: K170581(Special)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
2555 Davie Rd SE DECISION MADE: 11-MAY-17
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Partial Knee Application
MAKO Surgical Corp. 510(k) NO: K170584(Special)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
2555 Davie Rd SE DECISION MADE: 11-MAY-17
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strep B Carrot Broth One-Step
Hardy Diagnostics 510(k) NO: K170586(Traditional)
ATTN: Christopher Massey PHONE NO : 805 3462766 5620
1430 West McCoy Lane SE DECISION MADE: 22-MAY-17
Santa Maria CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.B.S. osteosynthesis screws
In2Bones SAS 510(k) NO: K170594(Special)
ATTN: Morgane Grenier PHONE NO : 33 4 72292626
28 Chemin du Petit Bois SE DECISION MADE: 10-MAY-17
ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoWay Laser System
Syneron Candela Corporation 510(k) NO: K170597(Traditional)
ATTN: Ruthie Amir PHONE NO : 508 3587400 330
530 Boston Post Road SE DECISION MADE: 25-MAY-17
Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tao Brush I.U.M.C. Endometrial Sampler
Cook Incorporated 510(k) NO: K170603(Traditional)
ATTN: Ian Herman PHONE NO : 812 3353575 104034
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 24-MAY-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Respiratory Panel 2 (RP2)
BioFire Diagnostics, LLC 510(k) NO: K170604(Traditional)
ATTN: Kristen J. Kanack PHONE NO : 801 7366354 330
515 Colorow Drive SE DECISION MADE: 30-MAY-17
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SETx Pedicle Screw System
Xenco Medical, LLC 510(k) NO: K170611(Traditional)
ATTN: Gustavo Prado PHONE NO : 858 2021505
9930 Mesa Rim Road SE DECISION MADE: 25-MAY-17
San Diego CA 92121 510(k) STATEMENT
DEVICE: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
Alma Lasers Inc. 510(k) NO: K170626(Traditional)
ATTN: Rekha Anand PHONE NO : 224 3772000 2019
485 Half Day Road Suite # 100 SE DECISION MADE: 31-MAY-17
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALIX ADVANCE Anchor with PERMATAPE Suture
Medos International SARL 510(k) NO: K170639(Traditional)
ATTN: Julie Vafides PHONE NO :
Chemin-Blanc 38, Case Postale SE DECISION MADE: 18-MAY-17
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connector System
Orthofix Inc. 510(k) NO: K170647(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 11-MAY-17
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTHEM CR Total Knee System
Smith & Nephew, Inc. 510(k) NO: K170648(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
7135 Goodlett Farms Parkway SE DECISION MADE: 11-MAY-17
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Orthofix Srl 510(k) NO: K170650(Special)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via Delle Nazioni 9 SE DECISION MADE: 10-MAY-17
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lympha Press Optimal Plus
Mego Afek AC Ltd. 510(k) NO: K170658(Traditional)
ATTN: Reuven Yunger PHONE NO : 972 77 9084276
Kibbutz Afek SE DECISION MADE: 31-MAY-17
Kibbutz Afek IL 3004200 510(k) STATEMENT
DEVICE: IQ Technologies
IQ Technologies Inc. 510(k) NO: K170659(Special)
ATTN: Elli Josef PHONE NO : 702 2608829
6672 Spencer St., Ste 800 SE DECISION MADE: 26-MAY-17
Las Vegas NV 89119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
bioMerieux, Inc. 510(k) NO: K170670(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 31-MAY-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
Medtronic Sofamor Danek 510(k) NO: K170679(Traditional)
ATTN: Kanesha Hines PHONE NO : 901 3992670
1800 Pyramid Place SE DECISION MADE: 11-MAY-17
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEVADAPTOR Closed Drug Reconstitution and Transfer System
Teva Medical Ltd., Migada Plant 510(k) NO: K170680(Special)
ATTN: Nadav Reuben PHONE NO : 972 4 6908826
North Industrial Zone SE DECISION MADE: 16-MAY-17
Kiryat Shmona IL 10258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Respire Pink Series with DentiTrac
Respire Medical Holding 510(k) NO: K170692(Traditional)
ATTN: Jonathan Sandler PHONE NO : 718 6437326
18 Bridge Street, Suite 4J SE DECISION MADE: 26-MAY-17
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenaCure EVLT NeverTouch Direct Introducer Sheath
AngioDynamics, Inc. 510(k) NO: K170695(Traditional)
ATTN: Robin Fuller PHONE NO : 508 6587986
26 Forest Street SE DECISION MADE: 30-MAY-17
Marlborough, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLY(TM) Bone Screws
Providence Medical Technology, Inc510(k) NO: K170698(Traditional)
ATTN: Margaret Wong PHONE NO : 415 9239376
1331 N. California Blvd., Suite 32SE DECISION MADE: 31-MAY-17
Walnut Creek CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex TruFocus LIO Premiere
Iridex Corporation 510(k) NO: K170718(Traditional)
ATTN: Gloria Dy PHONE NO : 650 6058807
1212 Terra Bella Avenue SE DECISION MADE: 03-MAY-17
Mountain View CA 94043-1824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanX Intraoral View
Duerr Dental AG 510(k) NO: K170733(Traditional)
ATTN: Oliver Lange PHONE NO : 49 7142 7050
Hopfigheimer Strasse 17 SE DECISION MADE: 01-MAY-17
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Silk.expert
Cyden Limited 510(k) NO: K170734(Special)
ATTN: Mike Kiernan PHONE NO : 44 1792 485519
Technium 2, Kings Road, The Docks SE DECISION MADE: 08-MAY-17
Swansea GB Sa1 8pJ 510(k) STATEMENT
DEVICE: GORE VIABIL Short Wire Biliary Endoprosthesis
W.L. Gore & Associates, Inc. 510(k) NO: K170740(Traditional)
ATTN: Barbara L. Smith PHONE NO : 410 5068189
301 Airport Road SE DECISION MADE: 08-MAY-17
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adhesive Electrodes
Reno Medical Ltd. 510(k) NO: K170744(Traditional)
ATTN: LiMing Ren PHONE NO : 86 575 82576147
MNC2246 RM1007, 10/F, Ho King CommSE DECISION MADE: 08-MAY-17
Hongkong CN 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEC Elite
OEC Medical Systems, Inc. 510(k) NO: K170752(Traditional)
ATTN: Helen Peng PHONE NO : 262 4248222
384 Wright Brothers Drive SE DECISION MADE: 19-MAY-17
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VariAx 2 Foot System
Stryker GmbH 510(k) NO: K170771(Traditional)
ATTN: Paul Nelson PHONE NO : 201 8315691
325 Corporate Drive SE DECISION MADE: 08-MAY-17
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bovie J-Plasma Precise FLEX Handpiece
Bovie Medical Corporation 510(k) NO: K170777(Traditional)
ATTN: Rubiela Maldonado PHONE NO : 727 8038508
5115 Ulmerton Road SE DECISION MADE: 01-MAY-17
Clearwater FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
Terang Nusa Sdn Bhd 510(k) NO: K170779(Special)
ATTN: Robert Hill PHONE NO : 60 977 47171
1 Jalan 8, Pengkalan Chepa 2, InduSE DECISION MADE: 24-MAY-17
Kota Bharu MY 16100 510(k) STATEMENT
DEVICE: PNEUMOCLEAR
W.O.M World Of Medicine GmbH 510(k) NO: K170784(Traditional)
ATTN: Soeren Markworth PHONE NO : 011 49 3039981594
Salzufer 8 SE DECISION MADE: 15-MAY-17
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: In Reach
CurveBeam, LLC 510(k) NO: K170789(Third Party - Traditional)
ATTN: Stuti Singh PHONE NO : 267 4838081
175 Titus Ave Suite 300 SE DECISION MADE: 05-MAY-17
Warrington PA 18976 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: The Solstice OCT System
Life Spine Inc. 510(k) NO: K170804(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 18-MAY-17
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc. 510(k) NO: K170828(Abbreviated)
ATTN: Nicole Bush PHONE NO : 1 203 4814183
11 Business Park Drive SE DECISION MADE: 17-MAY-17
Branford CT 06405 510(k) STATEMENT
DEVICE: EpiAccess System
EpiEP, INc 510(k) NO: K170831(Special)
ATTN: Pamela Bunes PHONE NO : 1 434 9510444
195 Church Street, 17th Floor SE DECISION MADE: 09-MAY-17
New Haven CT 06510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID Web
Given Imaging Ltd. 510(k) NO: K170839(Traditional)
ATTN: Hilla Debby PHONE NO : 972 4 9097774
2 Hacarmel St New Industrial Park SE DECISION MADE: 26-MAY-17
Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eko Model E5 System (EME5), Eko DUO
Eko Devices, Inc. 510(k) NO: K170874(Traditional)
ATTN: Connor Landgraf PHONE NO : 1 844 3563384
2600 10th St, Suite 260 SE DECISION MADE: 19-MAY-17
Berkeley CA 94710 510(k) STATEMENT
DEVICE: Mako Partial Knee Application
MAKO Surgical Corp. 510(k) NO: K170891(Traditional)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
2555 Davie Rd SE DECISION MADE: 24-MAY-17
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
Liofilchem s. r. l. 510(k) NO: K170892(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 25-MAY-17
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: 27HJ713S
LG Electronics 510(k) NO: K170899(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 30-MAY-17
Pyeongtaek-si KR 17709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK AIM
Gyrus ACMI Inc. 510(k) NO: K170908(Traditional)
ATTN: Graham A. L. Baillie PHONE NO : 508 8042690
136 Turnpike Road SE DECISION MADE: 19-MAY-17
Southborough MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LCD Monitor (MD310C, MD310G, MD210G)
BenQ Corporation 510(k) NO: K170944(Traditional)
ATTN: Calvin KT Chang PHONE NO : 886 2 26588880
16 Jihu Road, Neihu SE DECISION MADE: 25-MAY-17
Taipei TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable ECG Monitor
CONTEC Medical Systems Co.,Ltd 510(k) NO: K170954(Traditional)
ATTN: Xueyong Li PHONE NO : 86 335 8015489
No.112 Qinhuang West Street, EconoSE DECISION MADE: 30-MAY-17
Qinhuangdao CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Televere Digital Imaging System
Televere Systems 510(k) NO: K170975(Traditional)
ATTN: Randell Quaal PHONE NO : 800 3859593
1160 Cavalier Rd SE DECISION MADE: 01-MAY-17
Arnold MD 21012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESHOT Distal Targeting System V4.0 Trauma Interface
Smith & Nephew, Inc. 510(k) NO: K170977(Special)
ATTN: Allison Chan PHONE NO : 901 3991098
1450 Brooks Rd SE DECISION MADE: 03-MAY-17
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dymaxeon Spine System
Back 2 Basics Direct, LLC 510(k) NO: K170989(Traditional)
ATTN: Mitchell Bass PHONE NO : 216 4475025
6701 Rockside Road, Suite 200 SE DECISION MADE: 22-MAY-17
Independence OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
Spiration, Inc. 510(k) NO: K170990(Traditional)
ATTN: Cheryl Frederick PHONE NO : 425 6365535
6675 185th Avenue NE SE DECISION MADE: 11-MAY-17
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silhouette Featherlift
Silhouette Lift Inc. 510(k) NO: K171005(Special)
ATTN: Anthony DiBernardo PHONE NO : 949 7272074
1 Technology Drive F211 SE DECISION MADE: 03-MAY-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Knotless SutureTak Anchor
Arthrex Inc. 510(k) NO: K171020(Traditional)
ATTN: David L Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 16-MAY-17
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablation Confirmation
NeuWave Medical, Inc. 510(k) NO: K171022(Special)
ATTN: Dan Kosednar PHONE NO : 608 5121592
3529 Anderson Street SE DECISION MADE: 09-MAY-17
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nova StatSensor Creatinine Hospital Meter System
Nova Biomedical Corporation 510(k) NO: K171059(Special)
ATTN: Paul W. MacDonald PHONE NO : 781 6473700
200 Prospect Street SE DECISION MADE: 26-MAY-17
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Latex Cystatin C; N Protein Standard UY
Siemens Healthcare Diagnostics Pro510(k) NO: K171072(Traditional)
ATTN: Christine Perkins PHONE NO : 302 6318811
Emil-von-Behring-Str. 76 SE DECISION MADE: 12-MAY-17
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Video Endoscope System
Zhuhai Pusen Medical Technology Co510(k) NO: K171076(Third Party - Traditional)
ATTN: Wang ChangShen PHONE NO : 086 756 6880096
5/F, Building 1, No 33, Keji San RSE DECISION MADE: 05-MAY-17
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALP IFCC Gen.2
Roche Diagnostics Operations (RDO)510(k) NO: K171080(Special)
ATTN: Patrick Stimart PHONE NO : 317 5213954
9115 Hague Road SE DECISION MADE: 10-MAY-17
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guider Catheter Introducer
Rhythm Xience, Inc. (RXI) 510(k) NO: K171081(Third Party - Traditional)
ATTN: James Hassett PHONE NO : 952 4797903
10025 Valley View Road, Suite 130 SE DECISION MADE: 09-MAY-17
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
Orthofix Inc. 510(k) NO: K171082(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 05-MAY-17
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iChemVELOCITY Automated Urine Chemistry System
Iris Diagnostics, a Division of Ir510(k) NO: K171083(Traditional)
ATTN: Nancy Nadler PHONE NO : 305 3804191
9172 Eton Avenue SE DECISION MADE: 12-MAY-17
Chatsworth CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMR40
NeuroLogica Corporation, a Subsidi510(k) NO: K171085(Traditional)
ATTN: Ninad Gujar PHONE NO : 978 5648503
Samsung Electronics Co., Ltd 14 ElSE DECISION MADE: 11-MAY-17
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermi Reusable Non-invasive RF Electrode
ThermGen, L.L.C 510(k) NO: K171094(Traditional)
ATTN: Suzanne Cheang PHONE NO : 214 8880683
8304 Esters Boulevard Suite 890 SE DECISION MADE: 08-MAY-17
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fujifilm Diathermic Slitter (FlushKnife)
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171096(Special)
ATTN: Jeffrey Wan PHONE NO : 973 6862627
10 High Point Drive SE DECISION MADE: 09-MAY-17
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOJAVE Expandable Interbody System
K2M, Inc. 510(k) NO: K171097(Special)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 10-MAY-17
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIS Image Management System
Sonomed, Inc. 510(k) NO: K171098(Third Party - Traditional)
ATTN: Mark Wallace PHONE NO : 414 7457870
1979 Marcus Ave, Suite C105 SE DECISION MADE: 02-MAY-17
New Hyde Park NY 11042 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GM85
Samsung Electronics Co.,Ltd. 510(k) NO: K171119(Traditional)
ATTN: Chulsin Kim PHONE NO : 82 31 2007661
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 12-MAY-17
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nucleus Image Management System
NucleusHealth, LLC 510(k) NO: K171130(Third Party - Traditional)
ATTN: Linda Moore PHONE NO : 858 5463800
13280 Evening Creek Dr. SE DECISION MADE: 04-MAY-17
San Diego CA 91928 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Lipogems System
Lipogems International SpA 510(k) NO: K171135(Traditional)
ATTN: Carlo Russo PHONE NO : 39 02 37072408
viale Bianca Maria 24 SE DECISION MADE: 18-MAY-17
Milano IT 20129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVS 2430W, EVS 2430GW
DRTECH Corporation 510(k) NO: K171137(Special)
ATTN: Choul-Woo Shin PHONE NO : 82 31 7797783
Suite No. 2, 3 Floor, 29 Dunchon-dSE DECISION MADE: 15-MAY-17
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation 510(k) NO: K171138(Special)
ATTN: Catherine Mulcahy PHONE NO : 315 2346800
121 Metropolitan Drive SE DECISION MADE: 17-MAY-17
Liverpool NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaparoLight Veress Needle
Buffalo Filter, LLC 510(k) NO: K171139(Third Party - Traditional)
ATTN: Kyrylo Shvetsov PHONE NO : 716 8357000
5900 Genesee Street SE DECISION MADE: 18-MAY-17
Lancaster NY 14086 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc. 510(k) NO: K171141(Special)
ATTN: David L. Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 04-MAY-17
Naples FL 71924 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Universal Neuro III System AXS Screw
Stryker 510(k) NO: K171152(Special)
ATTN: Jonathan Schell PHONE NO : 269 3895596
750 Trade Centre Way, Suite 200 SE DECISION MADE: 19-MAY-17
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartByte Device
Scientific Intake 510(k) NO: K171165(Special)
ATTN: Marc Gibeley PHONE NO : 978 6262637
280 Merrimack Street Suite 503 SE DECISION MADE: 18-MAY-17
Lawrence MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immunodiagnostic Products Insulin Calibrators
Ortho Clinical Diagnostics 510(k) NO: K171168(Abbreviated)
ATTN: Bradley P. Boyer PHONE NO : 585 4533421
100 Indigo Creek Drive SE DECISION MADE: 16-MAY-17
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Medacta International SA 510(k) NO: K171170(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 25-MAY-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AS-10, CXDI-401RF
Canon, Inc. 510(k) NO: K171194(Traditional)
ATTN: Shinji Mori PHONE NO : 81 3 37582111
9-1, Imaikami-Cho,Nakahara-Ku SE DECISION MADE: 24-MAY-17
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
Osprey Medical, Inc. 510(k) NO: K171217(Special)
ATTN: Melanie Hess PHONE NO : 952 9558252
5600 Rowland Road Suite 250 SE DECISION MADE: 26-MAY-17
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELL UP3017 with QUBYX PerfectLum bundle
Qubyx Software Technologies Inc. 510(k) NO: K171229(Traditional)
ATTN: Marc Leppla PHONE NO : 518 6181012
501 Silverside Road, Suite 105 SE DECISION MADE: 26-MAY-17
Wilmington DE 19809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: My Dose Coach
Sanofi 510(k) NO: K171230(Special)
ATTN: Robert Ezzell PHONE NO : 617 7101418
640 Memorial Drive SE DECISION MADE: 26-MAY-17
Cambridge MA 02142 510(k) STATEMENT
DEVICE: Mistral-Air Warming Unit
The Surgical Company International510(k) NO: K171234(Third Party - Special)
ATTN: Kees van Hassel PHONE NO : 31 033 4507240
Beeldschermweg 6F SE DECISION MADE: 26-MAY-17
Amersfoort NL 3821 AH 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KARL STORZ ICG Imaging System
Karl Storz Endoscopy- America, Inc510(k) NO: K171238(Special)
ATTN: Winkie Wong PHONE NO : 424 2188288
2151 E. Grand Avenue SE DECISION MADE: 25-MAY-17
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
Medtronic 510(k) NO: K171253(Special)
ATTN: Debra Taitague PHONE NO : 234 2484186
1851 East Deere Ave SE DECISION MADE: 25-MAY-17
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
MicroTherapeutics, Inc. d/b/a ev3 510(k) NO: K171268(Traditional)
ATTN: Eric Elliott PHONE NO : 949 2975803
9775 Toledo Way SE DECISION MADE: 31-MAY-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci X Surgical System
Intuitve Surgical, Inc. 510(k) NO: K171294(Special)
ATTN: Brandon Hansen PHONE NO : 408 5237485
1266 Kifer Road SE DECISION MADE: 26-MAY-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SutureTape
Arthrex, Inc. 510(k) NO: K171296(Special)
ATTN: Ivette Galmez PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 26-MAY-17
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gammaCore-S
electroCore, LLC 510(k) NO: K171306(Special)
ATTN: Mike Romaniw PHONE NO : 973 2900097
150 Allen Road, Suite 201 SE DECISION MADE: 30-MAY-17
Basking Ridge NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB Advanced Quantification Software
Philips Healthcare 510(k) NO: K171314(Third Party - Traditional)
ATTN: Penny Greco PHONE NO : 508 8430282
3000 Minuteman Rd SE DECISION MADE: 30-MAY-17
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Tyber Medical Wedge System
Tyber Medical LLC 510(k) NO: K171327(Special)
ATTN: Mark F. Schenk PHONE NO : 610 8490645
83 S Commerce Way, Suite 310 SE DECISION MADE: 16-MAY-17
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B R A H M S PCT sensitive KRYPTOR
B.R.A.H.M.S GmbH 510(k) NO: K171338(Traditional)
ATTN: Sascha Johannes PHONE NO : 49 330 2883729
Neuendorfstr. 25 SE DECISION MADE: 31-MAY-17
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pinpoint GT Needle Guide Kits
C.R. Bard, Inc. 510(k) NO: K171348(Special)
ATTN: Christopher M. Phillips PHONE NO : 801 5225965
650 North 5600 West SE DECISION MADE: 22-MAY-17
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surefire Precision Infusion System
Surefire Medical, Inc. 510(k) NO: K171355(Third Party - Special)
ATTN: Lynne Aronson PHONE NO : 720 3059877
6272 W. 91st Avenue SE DECISION MADE: 17-MAY-17
Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EMS100 Tri-Wave Combination Stimulator
Elite Medical Supply of New York, 510(k) NO: K171387(Special)
ATTN: Jim Klett PHONE NO : 866 7120881___
1411 North Batavia Street Suite 11SE DECISION MADE: 31-MAY-17
Orange CA 92867 510(k) STATEMENT
DEVICE: EndoWrist Stapler 45 System and Stapler 45 Reloads
Intuitive Surgical, Inc. 510(k) NO: K171388(Special)
ATTN: Doreen Nakamura PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 31-MAY-17
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 296
TOTAL WITH SUMMARIES 278
TOTAL WITH STATEMENTS 18
