510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2018
DEVICE: Nitrile Patient Examination Powder Free Glove, Textured, Black
MULTISAFE SDN. BHD. 510(k) NO: K161085(Traditional)
ATTN: THUM TECK LAM PHONE NO : 605 4348269
LOT 764, BIDOR INDUSTRIAL ESTATE SE DECISION MADE: 05-JUL-18
BIDOR MY 35500 510(k) STATEMENT
DEVICE: Disposable Electrosurgical Pencils
Cathay Manfacturing Corp. 510(k) NO: K170369(Traditional)
ATTN: Ren Ren PHONE NO : 86 21 57878323
No.328,Xishe Road,Maogang Town,SonSE DECISION MADE: 19-JUL-18
Shanghai CN 201607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capnograph and Oximeter
CMI Health Inc. 510(k) NO: K170820(Traditional)
ATTN: Jiacheng Ren PHONE NO : 1 678 3893280
5975 Shiloh Road, Suite 114 SE DECISION MADE: 18-JUL-18
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical VIVIDEO ENT Videoscope Solution
Pentax Medical 510(k) NO: K171011(Traditional)
ATTN: James W. Monroe PHONE NO : 800 4315880 2129
3 Paragon Drive SE DECISION MADE: 18-JUL-18
Montvale NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook-Swartz Doppler Flow Probe
Cook Incorporated 510(k) NO: K171272(Traditional)
ATTN: Tom Kardos PHONE NO : 812 3353575 102607
750 Daniels Way P.O. Box 489 SE DECISION MADE: 17-JUL-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics Inc510(k) NO: K171274(Traditional)
ATTN: Matthew Gee PHONE NO : 914 2558782
511 Benedict Avenue SE DECISION MADE: 12-JUL-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qEEG-Pro
Brainmaster Technologies, Inc. 510(k) NO: K171414(Traditional)
ATTN: Tom Collura PHONE NO : 440 2326000
195 Willis Street, Suite 3 SE DECISION MADE: 01-JUL-18
Bedford OH 44146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Surgical Gloves, Powder Free
Sanrea Healthcare Products Pvt Ltd510(k) NO: K171550(Traditional)
ATTN: Jose Paul M PHONE NO : 91 491 2970145
Plot #P-56, Pearl Road Kinfra IIT SE DECISION MADE: 13-JUL-18
Palakkad IN 678 621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica IM High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics Inc510(k) NO: K171566(Traditional)
ATTN: Matthew Gee PHONE NO : 914 2558782
511 Benedict Avenue SE DECISION MADE: 19-JUL-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRAflow CNS System
IRRAS Inc. 510(k) NO: K171880(Traditional)
ATTN: Dessi Lyakov PHONE NO : 858 3366236
7452 Herschel Avenue SE DECISION MADE: 13-JUL-18
La Jolla CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-contact infrared body thermometer
Hetaida Technology Co., Ltd 510(k) NO: K171888(Traditional)
ATTN: ZhenGuang Chen PHONE NO : 86 139 23426692
4F, BaiShiDa High-Tech Park, XianDSE DECISION MADE: 23-JUL-18
DongGuan CN 523820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Autokeeper
MedExel Co.,Ltd. 510(k) NO: K172095(Traditional)
ATTN: Cha Dong Ik PHONE NO : 82 32 6778004
252, Geumgwangosan-ro, Geumgwang-mSE DECISION MADE: 24-JUL-18
Anseong-si KR 17535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 308nm Excimer System
Chongqing Peninsula Medical Techno510(k) NO: K172273(Traditional)
ATTN: Zhang Sudi PHONE NO : 86 150 12578550
No.2-4, 2F Block I, Ke Yuan 4th RoSE DECISION MADE: 30-JUL-18
Chongqing CN 400041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePTFE-Coated Auricular Implant
Implantech Associates Inc. 510(k) NO: K172389(Traditional)
ATTN: Craig Arthur PHONE NO : 805 3399415
6025 Nicolle St., Suite B SE DECISION MADE: 18-JUL-18
Ventura CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
Dongguan Prestige Sporting Goods.,510(k) NO: K172440(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
3rd Ind. District, Qiaotou Area HoSE DECISION MADE: 13-JUL-18
Dongguan CN 523950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High-speed Turbine Handpieces for Single Use
Beijing Dongbo Dental Handpiece Co510(k) NO: K172543(Traditional)
ATTN: Chengfei Yan PHONE NO : 86 10 80479758
Room 201, Building 4, No.9 Anqing SE DECISION MADE: 11-JUL-18
Beijing CN 101318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Beijing Safe Heart Technology Ltd.510(k) NO: K172616(Traditional)
ATTN: Xiaoming Yang PHONE NO : 86 10 61253661
Room 101, Unit 6, Building NO.6 NoSE DECISION MADE: 27-JUL-18
Beijing Economic-Technological Dev510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Power Infuser
ZOLL Medical Corporation 510(k) NO: K172653(Traditional)
ATTN: Pooja Dalvi PHONE NO : 978 8056293
269 & 271 Mill Road SE DECISION MADE: 18-JUL-18
Chelmsford MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Disposable Syringes
Shenyang MasTech Medical Device Co510(k) NO: K172694(Traditional)
ATTN: Liu Han PHONE NO : 86 24 24331351
Zhaojia Village, Qianjin Street DaSE DECISION MADE: 06-JUL-18
Shenyang CN 110165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CheckMyHeart Plus
DailyCare Biomedical, Inc 510(k) NO: K172778(Traditional)
ATTN: Ming Da Lee PHONE NO : 886 3 2631168
7f, No. 1, Ding-An Rd, Zhongli DisSE DECISION MADE: 05-JUL-18
Taoyuan City Taoyuan TW 320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latitud Hip Replacement System
Meril Healthcare Pvt. Ltd. 510(k) NO: K172857(Traditional)
ATTN: Bhavik Gondaliya PHONE NO : 91 968 7604713
Survey No. 135/2/B & 174/2, H11-H3SE DECISION MADE: 19-JUL-18
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable ECG Monitor (ECG3)
Andon Health Co., Ltd. 510(k) NO: K172862(Traditional)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street Ya An Road, SE DECISION MADE: 24-JUL-18
Tianjin CN 300190 510(k) STATEMENT
DEVICE: Infrared Thermometer
Shenzhen Jiacom Technology Co., Lt510(k) NO: K172874(Traditional)
ATTN: Luo Tianfeng PHONE NO : 86 755 29015600
No. A6 Building, Silicon Valley PoSE DECISION MADE: 12-JUL-18
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
Figaro Crowns, Inc. 510(k) NO: K172952(Traditional)
ATTN: Kyle Rose PHONE NO : 844 4344276
1628 Quail Ridge Circle SE DECISION MADE: 03-JUL-18
Woodbury MN 55125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMLS16-1
BioMedical Life Systems, Inc. 510(k) NO: K172971(Traditional)
ATTN: Gary Bussett PHONE NO : 760 7275600
P.O. Box 1360 SE DECISION MADE: 08-JUL-18
Vista CA 92085-1360 510(k) STATEMENT
DEVICE: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
GMAX Industries, Inc. 510(k) NO: K172987(Traditional)
ATTN: Julia Huang PHONE NO : 631 3484050 101
2150 joshua s path suite 205 SE DECISION MADE: 13-JUL-18
Hauppauge NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Dental Applicance
DaSoft Partners 510(k) NO: K172991(Abbreviated)
ATTN: Dante Togliatti PHONE NO : 619 4051530
4079 Governer Drive #111 SE DECISION MADE: 10-JUL-18
San Diego CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
Ethicon Inc. 510(k) NO: K173019(Traditional)
ATTN: Melina Escobar PHONE NO : 908 2182583
Route 22 West SE DECISION MADE: 06-JUL-18
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruMatch CMF Titanium 3D Printed Implant
Materialise NV 510(k) NO: K173039(Traditional)
ATTN: Lina Ramirez PHONE NO : 321 6396280
Technologielaan 15 SE DECISION MADE: 10-JUL-18
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vios Central Station Monitor Software, Vios Central Server Software
Vios Medical, Inc. 510(k) NO: K173107(Traditional)
ATTN: Amit Patel PHONE NO : 651 7648467
7300 Hudson Blvd N SE DECISION MADE: 26-JUL-18
St. Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Graft Natural Bone Substitute
Purgo Biologics Inc. 510(k) NO: K173188(Abbreviated)
ATTN: Hana Jung PHONE NO : 82 70 48274863
E-607, 700, Pangyo-ro Bundang-gu SE DECISION MADE: 20-JUL-18
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEKURE HbA1c Assay
Sekisui Diagnostics PEI Inc. 510(k) NO: K173206(Traditional)
ATTN: Penny White PHONE NO : 902 6280934
70 Watts Avenue SE DECISION MADE: 12-JUL-18
Charlottetown CA C1E 2B9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceevra Reveal 2.0
Ceevra, Inc. 510(k) NO: K173274(Traditional)
ATTN: Russ Yoshinaka PHONE NO : 415 3254830
180 Sansome St., 2nd Floor SE DECISION MADE: 10-JUL-18
San Francisco CA 94194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
Medline Industries, Inc. 510(k) NO: K173276(Traditional)
ATTN: Claire Pigman PHONE NO : 847 6434071
Three Lakes Drive SE DECISION MADE: 02-JUL-18
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA Guide Wire ASAHI SION black
Asahi Intecc Co., Ltd. 510(k) NO: K173277(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 485551
3-100 Akatsuki-cho SE DECISION MADE: 05-JUL-18
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIP/U.S. Urine Analysis Test System
Healthy.io Ltd 510(k) NO: K173327(Traditional)
ATTN: Ron Zohar PHONE NO : 972 54 4454514
27 Rothschild Boulevard SE DECISION MADE: 18-JUL-18
Tel Aviv IL 6688206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yikang Latex Foley Catheter
Jiangxi Yikang Medical Instrument 510(k) NO: K173340(Traditional)
ATTN: Nicholas Su PHONE NO : 86 791 85632226
No.188 LiduAihua Ave., Jinxian CouSE DECISION MADE: 13-JUL-18
Nanchang CN 331725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fractional CO2 Surgical Laser System
AMI Inc. 510(k) NO: K173359(Traditional)
ATTN: Hae Youn Lee PHONE NO : 82 2 3281 9091
RM. 1412, SJ Techno Ville, 278, BeSE DECISION MADE: 05-JUL-18
Seoul KR 80511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NicoletOne
Natus Neurology Incorporated 510(k) NO: K173366(Traditional)
ATTN: Shane T. Sawall PHONE NO : 608 8298673
3150 Pleasant View Road SE DECISION MADE: 20-JUL-18
Middleteon WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantitative Total Extensible Imaging (QTxI)
AIQ Solutions, Inc. 510(k) NO: K173444(Traditional)
ATTN: Dona Alberti PHONE NO : 608 7128585
8025 Excelsior Drive SE DECISION MADE: 23-JUL-18
Madison WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RetiCapture
Ilooda Co., Ltd. 510(k) NO: K173474(Traditional)
ATTN: Yun-Jung Ha PHONE NO : 82 31 2784660
120, Jangan-ro 458beon-gil, JanganSE DECISION MADE: 27-JUL-18
Suwon-Si KR 16200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NTU-USB Ultrasound USB Box
National Taiwan University 510(k) NO: K173486(Traditional)
ATTN: Pai-Chi Li PHONE NO : 886 2 33669637
No. 1, Sec. 4, Roosevelt Rd., TaipSE DECISION MADE: 11-JUL-18
Taipei TW 10617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® Pedicle Screw System
CarboFix Orthopedics Ltd. 510(k) NO: K173487(Traditional)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha’hoshlim St. SE DECISION MADE: 18-JUL-18
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActiveCare TD-4121 Blood Glucose Monitoring System
TaiDoc Technology Corporation 510(k) NO: K173511(Special)
ATTN: Sheena Song PHONE NO : 8862 66258188 1158
B1-7F, No. 127, Wugong 2nd Rd. WugSE DECISION MADE: 12-JUL-18
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Injection Screw
Biedermann Medtech, Inc. 510(k) NO: K173556(Traditional)
ATTN: Michelle Montesino PHONE NO : 786 4221400 106
7620 NW 25th Street Unit 3 & 4 SE DECISION MADE: 13-JUL-18
Miami FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Jason Membrane
Institut Straumann AG 510(k) NO: K173562(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260
Peter Merian Weg 12 SE DECISION MADE: 09-JUL-18
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc. 510(k) NO: K173585(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 19-JUL-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
Surgical Instrument Service and Sa510(k) NO: K173627(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 5164205
dba Medline ReNewal 1500 NE HemlocSE DECISION MADE: 12-JUL-18
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intelli-C
NRT X-ray A/S 510(k) NO: K173631(Traditional)
ATTN: Jan Malling PHONE NO : 45 86 283500
Birkegaardsvej 16 SE DECISION MADE: 11-JUL-18
Hasselager DK 8361 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JASPER Spinal Fixation System
GBS Commonwealth Co., Ltd. 510(k) NO: K173645(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
B-1007-1, Woolim Lion's Valley 168SE DECISION MADE: 23-JUL-18
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureteral Dilator Sets, Ureteral Dilators
Cook Incorporated 510(k) NO: K173654(Traditional)
ATTN: Kotei Aoki PHONE NO : 812 3353575 102630
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 17-JUL-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex FibuLock Nail
Arthrex, Inc. 510(k) NO: K173656(Special)
ATTN: Rebecca R. Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 26-JUL-18
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Howell D.A.S.H Extraction Balloon with Multiple Sizing
Wilson-Cook Medical, Inc 510(k) NO: K173659(Special)
ATTN: Tiffanny A. Thomas PHONE NO : 336 7440157 396680
4900 Bethania Station Road SE DECISION MADE: 06-JUL-18
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
ConvaTec Limited 510(k) NO: K173675(Traditional)
ATTN: Justin Lovelace PHONE NO : 1 336 5424745
First Avenue, Deeside Industrial PSE DECISION MADE: 20-JUL-18
Deeside GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
PENTAX of America, Inc. 510(k) NO: K173679(Traditional)
ATTN: James W. Monroe PHONE NO : 201 5712300
3 Paragon Drive SE DECISION MADE: 03-JUL-18
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureForm 60 and SureForm 60 Reloads
Intuitive Surgical 510(k) NO: K173721(Traditional)
ATTN: Nadine Nasr PHONE NO : 408 5237093
1266 Kifer Road SE DECISION MADE: 05-JUL-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
AngioDynamics, Inc. 510(k) NO: K173762(Special)
ATTN: Teri Juckett PHONE NO : 518 7951142
603 Queensbury Avenue SE DECISION MADE: 18-JUL-18
Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
Shen Wei USA Inc. 510(k) NO: K173766(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 08-JUL-18
Union City CA 94587 510(k) STATEMENT
DEVICE: BIOLOX delta Option and Extra-long Heads
MicroPort Orthopedics Inc. 510(k) NO: K173776(Traditional)
ATTN: Allen Mamaril PHONE NO : 901 8674551
5677 Airline Road SE DECISION MADE: 06-JUL-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K173797(Traditional)
ATTN: Adam Heroux PHONE NO : 781 8940800
200 Prospect St. SE DECISION MADE: 17-JUL-18
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment 510(k) NO: K173801(Special)
ATTN: Zhenhua Xiao PHONE NO : 86 0755 26413482
6C, Block 10, The Second IndustriaSE DECISION MADE: 11-JUL-18
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voutia™
Jeffrey Ward Cash, DDS 510(k) NO: K173808(Traditional)
ATTN: Jeffrey Ward Cash PHONE NO : 804 8379594
10149 Bon Air Crest Drive SE DECISION MADE: 27-JUL-18
North Chesterfield VA 23235-4868 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoLSD MSMS kit
Wallac Oy, a subsidiary of PerkinE510(k) NO: K173829(Traditional)
ATTN: Kay A Taylor PHONE NO : 317 4181735
940 Winter Street SE DECISION MADE: 18-JUL-18
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHMIA HDx Mapping System (with software Version 2.0)
Boston Scientific Corporation 510(k) NO: K173837(Traditional)
ATTN: Gregory Neal PHONE NO : 617 2183813
125 Cambridgepark Drive Suite 600 SE DECISION MADE: 25-JUL-18
Cambridge MA 02140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peekplus® Interbody Fusion Device
Vallum Corporation 510(k) NO: K173864(Traditional)
ATTN: Stephen Blinn PHONE NO : 603 5771989
61 Spit Brook Road SE DECISION MADE: 02-JUL-18
Nashua NH 03060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Serenity Body Position Sensor, Serenity RIP Sensors
Neurotronics, Inc. 510(k) NO: K173868(Traditional)
ATTN: David Pezet PHONE NO : 352 3729955
4500 NW 27th Ave Ste C2 SE DECISION MADE: 02-JUL-18
Gainesville FL 32606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
Owen Mumford Ltd 510(k) NO: K173881(Traditional)
ATTN: Darren Mansell PHONE NO : 011 44 1993812021
Brook Hill SE DECISION MADE: 11-JUL-18
Woodstock GB OX20 1TU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimension Hemoglobin A1c Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K173909(Traditional)
ATTN: Alan Haley PHONE NO : 302 6319883
P.O. Box 6101 M/S 514 SE DECISION MADE: 13-JUL-18
Newark DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Burn and Wound Dressing
Medline Industries, Inc. 510(k) NO: K173911(Traditional)
ATTN: Bethany Benoit-DiMaria PHONE NO : 847 6433256
Three Lakes Drive SE DECISION MADE: 19-JUL-18
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys BRAHMS PCT
Roche Diagnostics 510(k) NO: K173927(Traditional)
ATTN: Wes Gerbig PHONE NO : 317 5214371
9115 Hague Road SE DECISION MADE: 06-JUL-18
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CipherOx CRI M1
Flashback Technologies, Inc. 510(k) NO: K173929(Traditional)
ATTN: Gregory Z. Grudic PHONE NO : 720 2042575
80 Health Park Drive, Suite 20 SE DECISION MADE: 24-JUL-18
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental High-speed Handpiece and Accessories
MicroP Technology (Taiwan), Inc. 510(k) NO: K173943(Traditional)
ATTN: Ina Lin PHONE NO : 886 522 68808
No.40, Junghe Tsuen, Minshiung TowSE DECISION MADE: 24-JUL-18
Chiayi County TW 621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumbar Interbody Fusion System (OLLIF)
Advanced Research Medical, LLC 510(k) NO: K173947(Traditional)
ATTN: John D Siegel PHONE NO : 610 4575324
1519 Highway 13 East SE DECISION MADE: 25-JUL-18
Burnsville MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Variobase for Bridge/Bar Cylindrical
Institut Straumann AG 510(k) NO: K173968(Traditional)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Lochhamer Schlag 6 SE DECISION MADE: 17-JUL-18
Gräfelfing DE 82166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medicalgorithmics Unified Cardiac Rehabilitation System
Medicalgorithmics S.A. 510(k) NO: K173969(Abbreviated)
ATTN: Marek Dziubinski PHONE NO : 48 22 8251249
Aleje Jerozolimskie 81 SE DECISION MADE: 11-JUL-18
Warsaw PL 02-001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise PKA Guide System
Materialise NV 510(k) NO: K173970(Traditional)
ATTN: Oliver Clemens PHONE NO : 32 16396280
Technologielaan 15 SE DECISION MADE: 06-JUL-18
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TV-100
Bio-Med Devices, Inc. 510(k) NO: K173973(Traditional)
ATTN: Ken Close PHONE NO : 203 4580202
61 Soundview Road SE DECISION MADE: 20-JUL-18
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulmonx Chartis Tablet Console
Pulmonx Corporation 510(k) NO: K180011(Traditional)
ATTN: Sherry Kim PHONE NO : 650 2160189
700 Chesapeake Drive SE DECISION MADE: 13-JUL-18
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX40 Release C.01
Philips Medical Systems 510(k) NO: K180017(Special)
ATTN: Theresa Poole PHONE NO : 978 6597621
3000 Minuteman Road SE DECISION MADE: 24-JUL-18
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Hot Biopsy Forceps
Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K180018(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
NO. 10 Gaoke Third Road SE DECISION MADE: 05-JUL-18
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athena Cervical Plate System
Medyssey USA, Inc. 510(k) NO: K180022(Traditional)
ATTN: Shawn Kim PHONE NO : 847 4270200
1550 E. Higgins Road, Suite 123 SE DECISION MADE: 20-JUL-18
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALVATION Midfoot Nail
Wright Medical Technology, Inc. 510(k) NO: K180024(Traditional)
ATTN: Alayne Melancon PHONE NO : 901 2905986
1023 Cherry Road SE DECISION MADE: 11-JUL-18
Memphis TN 37117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSYTE 3D Fiducial Marker
Radiation Products LLC 510(k) NO: K180027(Traditional)
ATTN: John D Corbitt PHONE NO : 561 3796210
142 JFK Drive SE DECISION MADE: 18-JUL-18
Atlantis FL 33462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoFab Patient Specific Cranial Device
Oxford Performance Materials, Inc.510(k) NO: K180064(Traditional)
ATTN: M. Beth Pashko PHONE NO : 860 6989300
30 South Satellite Road SE DECISION MADE: 27-JUL-18
South Windsor CT 06074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ti 3Z Interbody System
Zavation Medical Products, LLc 510(k) NO: K180076(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 27-JUL-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWBM Pump
Taiwan Biomaterial Co., Ltd. 510(k) NO: K180115(Traditional)
ATTN: Monoj Mon Kalita PHONE NO : 886 3 6683088
6F, No. 26-1, Sec.2, Shengyi Rd. SE DECISION MADE: 24-JUL-18
Zhubei TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC3 Jugular Dual Lumen Catheter
MC3 Incorporated 510(k) NO: K180151(Traditional)
ATTN: Adam Viitala PHONE NO : 1 734 9959089
2555 Bishop Circle West SE DECISION MADE: 16-JUL-18
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Cepheid 510(k) NO: K180218(Dual Track)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 24-JUL-18
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREND II Spinal Fixation System- STEP Series
Paonan Biotech Co., Ltd. 510(k) NO: K180226(Traditional)
ATTN: Vivi Tsai PHONE NO : 886 2 26274366
3F, No. 50, Lane 258, Rueiguang RdSE DECISION MADE: 25-JUL-18
Taipei TW 11491 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EcoFit Vit E Acetabular System
implantcast Gmbh 510(k) NO: K180263(Traditional)
ATTN: Juliane Hoeppner PHONE NO : 49 4161 744135
Lueneburger Schanze 26 SE DECISION MADE: 20-JUL-18
Buxtehude DE 21614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell Apollo System
Cadwell Industries, Inc. 510(k) NO: K180269(Traditional)
ATTN: Alison Hull PHONE NO : 800 2453001 210
909 North Kellogg Street SE DECISION MADE: 17-JUL-18
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saniclave 250
REVOLUTIONARY SCIENCE 510(k) NO: K180272(Traditional)
ATTN: Isaac Erickson PHONE NO : 651 3537806
17319 Lake Blvd SE DECISION MADE: 26-JUL-18
Shafer MN 55074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Bolus Software
3D Bolus, Inc. 510(k) NO: K180289(Traditional)
ATTN: Peter Hickey PHONE NO : 1 902 4429091
1344 Summer St Suite 3015 SE DECISION MADE: 10-JUL-18
Halifax CA B3H 0A8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Xuzhou Yongkang Electronic Science510(k) NO: K180314(Traditional)
ATTN: Xuecheng Zhao PHONE NO : 86 516 87892766 631
4F Building C8,40 Jingshan Road EcSE DECISION MADE: 11-JUL-18
Xuzhou CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Field Orthopaedics Micro Screw System
Field Orthopaedics Pty. Ltd. 510(k) NO: K180348(Traditional)
ATTN: Christopher Jeffery PHONE NO : 61 401 249783
375 Wickham Terrace SE DECISION MADE: 17-JUL-18
Brisbane AU 4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureterorenoscope System
Shanghai AnQing Medical Instrument510(k) NO: K180367(Traditional)
ATTN: Lina FEI PHONE NO : 86 137 74253128
150 Cailun Road, Zhangjiang High-TSE DECISION MADE: 03-JUL-18
Shanghai CN 201210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smartinhaler
Adherium (NZ) Ltd 510(k) NO: K180407(Traditional)
ATTN: Chris Mander PHONE NO : 64 9 3072771
Level 2, 204 Quay Street SE DECISION MADE: 25-JUL-18
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Doppler (Model YM-2T8)
Shenzhen IMDK Medical Technology C510(k) NO: K180419(Traditional)
ATTN: Yuan Xia PHONE NO : 86 136 62694320
C Zone, 10F, Building16, Yuanshan SE DECISION MADE: 19-JUL-18
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
Covidien, llc 510(k) NO: K180485(Traditional)
ATTN: Carol Ming PHONE NO : 508 4521443
15 Hampshire Street SE DECISION MADE: 27-JUL-18
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GammaTile
Isoray Medical Inc. 510(k) NO: K180515(Traditional)
ATTN: Bill Joy PHONE NO : 509 3751202
350 Hills Street, Suite 106 SE DECISION MADE: 06-JUL-18
Richland WA 99354 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GME LinScan Lite 808 Laser System
GME German Medical Engineering Gmb510(k) NO: K180518(Traditional)
ATTN: Stefan Schulze PHONE NO : 49 9131 93415910
Grimmstrasse 23 SE DECISION MADE: 23-JUL-18
Nuerenberg DE 90491 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIDON FA
CenterVue SpA 510(k) NO: K180526(Traditional)
ATTN: Roberto Gabriotti PHONE NO : 39 049 5018399
Via S. Marco 9H SE DECISION MADE: 16-JUL-18
Padova IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips IntelliVue GuardianSoftware
Philips Medizin Systeme Boeblingen510(k) NO: K180534(Traditional)
ATTN: Michael Asmalsky PHONE NO : 49 7031 4631277
Hewlett-Packard Str. 2 SE DECISION MADE: 16-JUL-18
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Static Staples
Synthes (USA) Products, LLC 510(k) NO: K180544(Traditional)
ATTN: Suchitra Basu PHONE NO : 1 610 7195448
1301 Goshen Parkway SE DECISION MADE: 24-JUL-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modified Novy Cornual Cannulation Set
Cook Incorporated 510(k) NO: K180552(Special)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 12-JUL-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corelink Foundation 3D Anterior Lumbar System
Corelink, LLC 510(k) NO: K180556(Special)
ATTN: Steven D. Mounts PHONE NO : 888 3497808
7911 Forsyth Blvd, Suite # 200 SE DECISION MADE: 27-JUL-18
St. Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
Olympus Medical Systems Corp. 510(k) NO: K180575(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 12-JUL-18
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
Surgical Instrument Service and Sa510(k) NO: K180580(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 9233375
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 27-JUL-18
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical PT Interbody Spacer System
Tyber Medical, LLC 510(k) NO: K180590(Traditional)
ATTN: Mark F Schenk PHONE NO : 610 8490645
83 South Commerce Way Suite 310 SE DECISION MADE: 06-JUL-18
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Estelite Universal Flow
Tokuyama Dental Corporation 510(k) NO: K180613(Traditional)
ATTN: Keith A. Barritt PHONE NO : 202 7835070
38-9 Taitou 1-chome, Taitou-ku SE DECISION MADE: 12-JUL-18
Tokyo JP 110-0016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Macroduct Advanced Model 3710
ELITechGroup Inc. 510(k) NO: K180627(Traditional)
ATTN: Stacey Pahulu PHONE NO : 435 7526011
370 W 1700 S SE DECISION MADE: 27-JUL-18
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DentiqGuide
3D Industrial Imaging Co., Ltd 510(k) NO: K180629(Traditional)
ATTN: Jin Sa Kim PHONE NO : 82 70 87669192
413 Institute of Computer TechnoloSE DECISION MADE: 19-JUL-18
Seoul KR 08826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Equinoxe Small Reverse Shoulder System
Exactech Inc. 510(k) NO: K180632(Special)
ATTN: Zach Sharrah PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 25-JUL-18
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINXEL-RF system
Rohrer Aesthetics, LLC 510(k) NO: K180654(Traditional)
ATTN: Mark Rohrer PHONE NO : 205 3561172
105 Citation Court SE DECISION MADE: 13-JUL-18
Homewood AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viking Lumbar Polyaxial Screw System
Presidio Surgical 510(k) NO: K180655(Traditional)
ATTN: Meredith Lee May PHONE NO : 719 3377579
1451 Danville Blvd. Suite 204 SE DECISION MADE: 13-JUL-18
Alamo CA 94507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Normandy VBR System
Zavation Medical Products LLC 510(k) NO: K180673(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 13-JUL-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FBC 921 (ALIF)
FBC Device ApS 510(k) NO: K180695(Traditional)
ATTN: Finn Bjarke Christensen PHONE NO : 45 7878 7979
Viengevej 100 SE DECISION MADE: 12-JUL-18
Risskov DK 8240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pseudo-Patient
RTsafe, Inc. 510(k) NO: K180697(Traditional)
ATTN: Dimitris Makris PHONE NO : 210 5425822
342 Regent Circle SE DECISION MADE: 10-JUL-18
San Antonio TX 78231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Riptide Aspiration System React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K180705(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 2975489
9775 Toledo Way SE DECISION MADE: 04-JUL-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K180715(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 2975489
9775 Toledo Way SE DECISION MADE: 04-JUL-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspire Introducer Needle
Aspire Bariatrics, Inc. 510(k) NO: K180725(Traditional)
ATTN: Monica Ferrante PHONE NO : 484 2001031
3200 Horizon Drive, Suite 100 SE DECISION MADE: 11-JUL-18
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVISION Total Ankle Revision System
Wright Medical Technology, Inc. 510(k) NO: K180730(Traditional)
ATTN: Alayne Melancon PHONE NO : 901 2905986
1023 Cherry Road SE DECISION MADE: 11-JUL-18
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
Corinth MedTech, Inc. 510(k) NO: K180752(Traditional)
ATTN: Sandeep Saboo PHONE NO : 408 9962517
1601 S. De Anza Blvd, Suite 221 SE DECISION MADE: 25-JUL-18
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vail ALIF Buttress Plate System
Evolution Spine, LLC 510(k) NO: K180755(Traditional)
ATTN: Douglas Davis PHONE NO : 214 2286252
2300 North Haskell Ave SE DECISION MADE: 06-JUL-18
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CuffLink Implant System Biocomposite
CONMED Corporation 510(k) NO: K180763(Traditional)
ATTN: Diana L. Nader-Martone PHONE NO : 727 3995425
525 French Road SE DECISION MADE: 19-JUL-18
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
ASAHI INTECC CO., LTD. 510(k) NO: K180784(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 485551
3-100 Akatsuki-cho SE DECISION MADE: 18-JUL-18
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prime Acetabular Cup System
MicroPort Orthopedics Inc. 510(k) NO: K180798(Traditional)
ATTN: Sarah Evonne Stroupe PHONE NO :
5677 Airline Road SE DECISION MADE: 09-JUL-18
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziehm RFD 3D Tracker
Medtronic Navigation 510(k) NO: K180816(Traditional)
ATTN: Nicole Zimmerman PHONE NO : 720 8902342
826 Coal Creek Circle SE DECISION MADE: 11-JUL-18
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyager Trajectory Array Guide (V-TAG)
Voyager Therapeutics, Inc. 510(k) NO: K180854(Traditional)
ATTN: Lynn E Bayless PHONE NO : 857 2595340
75 Sidney Street SE DECISION MADE: 23-JUL-18
Cambridge MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCHMAN TruSeal Access System
Boston Scientific 510(k) NO: K180864(Traditional)
ATTN: Nikki M Ibis PHONE NO : 763 4942381
Three Scimed Place SE DECISION MADE: 20-JUL-18
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
Cook Ireland 510(k) NO: K180868(Traditional)
ATTN: Jacinta Kilmartin PHONE NO : 011 353 61239483
O'Halloran Road National TechnologSE DECISION MADE: 06-JUL-18
Limerick IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
3M Health Care 510(k) NO: K180874(Traditional)
ATTN: Linda Johnsen PHONE NO : 651 4303467
3M Center, 2510 Conway Ave, BuildiSE DECISION MADE: 31-JUL-18
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Light Therapy Device
Uvbiotek, LLC 510(k) NO: K180900(Traditional)
ATTN: Dave Oberhelman PHONE NO : 518 7473310
3 Depot Street, Hudson Falls SE DECISION MADE: 10-JUL-18
New York NY 12839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAPRO Mesh and ULTRAPRO ADVANCED
Ethicon Inc 510(k) NO: K180910(Traditional)
ATTN: Melina Escobar PHONE NO : 908 2182583
Route 22 West P.O Box 151 SE DECISION MADE: 02-JUL-18
Somerville NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TE7/TE5 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K180912(Traditional)
ATTN: Yang Zhaohui PHONE NO : 86 755 81885640
Mindray Building, Keji 12th Road SSE DECISION MADE: 30-JUL-18
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonicision Reusable Sterilization Tray
Covidien 510(k) NO: K180915(Traditional)
ATTN: Candice Bautista-Biddle PHONE NO : 303 5306448
5920 Longbow Drive SE DECISION MADE: 17-JUL-18
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Personal Lubricating Jelly
Perrigo New York, Inc. 510(k) NO: K180923(Traditional)
ATTN: Karen Dombrowski PHONE NO : 269 6739149
1700 Bathgate Ave. SE DECISION MADE: 09-JUL-18
Bronx NY 10457-7512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR VVC TIBIAL INSERT
Encore Medical, L.P. 510(k) NO: K180930(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 09-JUL-18
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Telavancin (TLA) (0.002-32 ug/mL)
bioMerieux SA 510(k) NO: K180936(Traditional)
ATTN: Asa Karlsson PHONE NO : 33 06 48616849
376 Chemin de l'Orme SE DECISION MADE: 03-JUL-18
Marcy L'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi NAV Suction Instruments
Acclarent, Inc. 510(k) NO: K180948(Traditional)
ATTN: Leena Sorathia PHONE NO : 714 2640615
33 Technology Drive SE DECISION MADE: 20-JUL-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
Shockwave Medical, Inc. 510(k) NO: K180958(Traditional)
ATTN: Cindy Morrow PHONE NO : 510 6249266
48501 Warm Springs Blvd, Suite 108SE DECISION MADE: 26-JUL-18
Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXIT / ComposiTCP Threaded Anchor System
S.B.M. SAS Sciences for Bio Materi510(k) NO: K180960(Special)
ATTN: Anne Cospin-Latapie PHONE NO : 00 33 562422101
ZI du Monge SE DECISION MADE: 25-JUL-18
Lourdes FR 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCCIA ALIF, ROCCIA TLIF
Silony Medical GmbH 510(k) NO: K180963(Traditional)
ATTN: Bircan Tasdelen PHONE NO : 49 711 78252540
Leinfelder Straße 60 SE DECISION MADE: 11-JUL-18
Leinfelden-Echterdingen DE d-7077510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Diode Laser System
Lazon Medical Laser Co., Ltd. 510(k) NO: K180967(Traditional)
ATTN: Gen Cheng PHONE NO : 86 024 88327588
No.123, Hezuo Street, Dadong DistrSE DECISION MADE: 11-JUL-18
Shenyang CN 110179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable guides KDNG00
Koelis 510(k) NO: K180970(Traditional)
ATTN: Pauline Nicole PHONE NO : 33 04 58176810
16, chemin du vieux chene SE DECISION MADE: 10-JUL-18
Meylan FR 38240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ New Generation Trocars
KARL STORZ Endoscopy-America, Inc.510(k) NO: K180977(Traditional)
ATTN: AnnaLisa Smullin PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 18-JUL-18
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica IM BRAHMS Procalcitonin (PCT)
Siemens Healthcare Diagnostics Inc510(k) NO: K181002(Traditional)
ATTN: Fatima Pacheco PHONE NO : 914 3743770
511 Benedict Ave SE DECISION MADE: 16-JUL-18
Tarrytown NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIM2
GC America Inc. 510(k) NO: K181011(Traditional)
ATTN: Mark Heiss PHONE NO : 708 5970900
3737 W. 127th Street SE DECISION MADE: 12-JUL-18
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium PL Cage
Stryker Spine 510(k) NO: K181014(Traditional)
ATTN: Travis Catania PHONE NO : 201 7498038
2 Pearl Court SE DECISION MADE: 18-JUL-18
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braun BFH175 Infrared Forehead Thermometer
Kaz USA, Inc., A Helen of Troy Com510(k) NO: K181015(Special)
ATTN: Matt J. Baun PHONE NO : 508 4907240
400 Donald Lynch Boulevard, Suite SE DECISION MADE: 18-JUL-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Welch Allyn, Inc. 510(k) NO: K181016(Traditional)
ATTN: Megan Pellenz PHONE NO : 1 315 6854696
4341 State Street Rd. SE DECISION MADE: 16-JUL-18
Skaneateles Falls NY 13153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Free Testosterone AccuBind ELISA Test System
Monobind Inc. 510(k) NO: K181017(Traditional)
ATTN: Anthony Shatola PHONE NO : 949 9512665
100 North Pointe Drive SE DECISION MADE: 20-JUL-18
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser System
Guangzhou Huafei Tongda Technology510(k) NO: K181019(Traditional)
ATTN: Liu Pengqi PHONE NO : 86 13 302285919
4/F, Building B Industrial and ComSE DECISION MADE: 16-JUL-18
Huadi Dadao Nan Road, Fangcun, Liw510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
Neuro Kinetics, Inc. 510(k) NO: K181025(Special)
ATTN: Robin C. Ashmore PHONE NO : 412 9636649
128 Gamma Drive SE DECISION MADE: 24-JUL-18
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solana Bordetella Complete Assay
Quidel Corporation 510(k) NO: K181029(Traditional)
ATTN: Ronald H. Lollar PHONE NO : 740 5893373
2005 East State Street, Suite 100 SE DECISION MADE: 15-JUL-18
Athens OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rubicon Lumbar Interbody Fusion System
Rubicon Spine, LLC 510(k) NO: K181030(Traditional)
ATTN: Mike Boyer PHONE NO : 888 5152532
2955-B Bee Ridge Road SE DECISION MADE: 17-JUL-18
Sarasota FL 34239 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatStrip Glucose Hospital Meter System
Nova Biomedical Corporation 510(k) NO: K181043(Dual Track)
ATTN: John Mchale PHONE NO : 781 8940800 1321
200 Prospect Street SE DECISION MADE: 12-JUL-18
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 400um Perforator and Accessory Vein Ablation Kit
AngioDynamics, Inc. 510(k) NO: K181044(Traditional)
ATTN: Deepa R. Godhiya PHONE NO : 508 6587923
26 Forest Street SE DECISION MADE: 05-JUL-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra Facial Toning System
Micro Current Technology, Inc. 510(k) NO: K181062(Traditional)
ATTN: David Suzuki PHONE NO : 206 7741133
2244 1st Ave. South SE DECISION MADE: 18-JUL-18
Seattle WA 98134 510(k) STATEMENT
DEVICE: Kestrel™ Buttress Plate System
Innovasis, Inc. 510(k) NO: K181063(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 13-JUL-18
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Regatta Lateral System
SeaSpine Orthopedics Corporation 510(k) NO: K181079(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 18-JUL-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker All-PEEK Knotless Anchor System
Stryker 510(k) NO: K181083(Traditional)
ATTN: Katie Farraro PHONE NO : 408 7542285
5900 Optical Ct. SE DECISION MADE: 23-JUL-18
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMID CARBA agar (CARB)
bioMerieux SA 510(k) NO: K181092(Traditional)
ATTN: Asa Karlsson PHONE NO : 33 06 48616849
376 Chemin de l'Orme SE DECISION MADE: 06-JUL-18
Marcy l'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF-Relief
EL Global Trade Ltd 510(k) NO: K181095(Traditional)
ATTN: Martin Gurovich PHONE NO : 972 9 7889069
8 Tzoran St, P.O. Box 8242 SE DECISION MADE: 24-JUL-18
Netanya IL 4250608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CxHA PEEK Cervical IBF System
Innovasis, Inc. 510(k) NO: K181115(Traditional)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 16-JUL-18
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
Sunstar Americas Inc 510(k) NO: K181134(Traditional)
ATTN: Liz Bastian PHONE NO : 847 7944231
301 E. Central Road SE DECISION MADE: 13-JUL-18
Schaumburg IL 60195 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC 510(k) NO: K181139(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3168 Lionshead Ave, Suite 100 SE DECISION MADE: 06-JUL-18
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther Fusion GBS Assay
Diagenode 510(k) NO: K181156(Traditional)
ATTN: Geraldine Poncin PHONE NO : 320 497 972257
Rue du Bois Saint Jean 3 SE DECISION MADE: 27-JUL-18
Seraing BE 4102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12F Tri-Flow Triple Lumen Catheter
Medical Components Inc. (Dba Medco510(k) NO: K181175(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 05-JUL-18
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-mini active Fixture
Neobiotech Co., Ltd. 510(k) NO: K181178(Traditional)
ATTN: Young-Ku Heo PHONE NO : 82 2 5822885
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 24-JUL-18
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC Intramedullary Nail System
The Orthopaedic Implant Company 510(k) NO: K181184(Special)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 27-JUL-18
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS Conus Structure
Dentsply Sirona 510(k) NO: K181189(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 W Philadelphia Street, Suite 6SE DECISION MADE: 18-JUL-18
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeriView FLEX
Olympus Surgical Technologies Amer510(k) NO: K181193(Special)
ATTN: Mary Anne Patella PHONE NO : 508 8042600
136 Turnpike Road SE DECISION MADE: 03-JUL-18
Southborough MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synermed ISE Reagents
Infrared Laboratory Systems, LLC (510(k) NO: K181201(Traditional)
ATTN: Julie Paschal PHONE NO : 317 8961565
17408 Tiller Court Suite 1900 SE DECISION MADE: 10-JUL-18
Westfield IN 40674 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Siemens Healthcare Diagnostics, In510(k) NO: K181213(Traditional)
ATTN: Kira Gordon PHONE NO : 914 5242996
511 Benedict Ave SE DECISION MADE: 30-JUL-18
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braun BNT400 No Touch + Forehead Thermometer
Kaz USA, Inc., A Helen of Troy Com510(k) NO: K181242(Special)
ATTN: Matt J. Baun PHONE NO : 508 4907240
400 Donald Lynch Boulevard, Suite SE DECISION MADE: 23-JUL-18
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Cervical Plate System
Zavation Medical Products LLC 510(k) NO: K181244(Traditional)
ATTN: Matt Jones PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 10-JUL-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation IBF System
Zavation Medical Products LLC 510(k) NO: K181246(Traditional)
ATTN: Matt Jones PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 10-JUL-18
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curiteva Cervical Interbody Fusion System
Curiteva, LLC 510(k) NO: K181261(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive Suite 100 SE DECISION MADE: 09-JUL-18
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLENE (Polypropylene) 3D Patch
Ethicon, Inc. 510(k) NO: K181268(Traditional)
ATTN: Melina Escobar PHONE NO : 908 2182583
Route 22 West P.O Box 151 SE DECISION MADE: 26-JUL-18
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Picocare Family
WON TECH Co., Ltd. 510(k) NO: K181272(Special)
ATTN: Hyunsik Yoon PHONE NO : 82 10 62509299
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 31-JUL-18
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONOD Enteral Feeding Sets
Conod Medical Co., Limited 510(k) NO: K181276(Traditional)
ATTN: Cheng Run PHONE NO : 86 057 181958619
No.38 Hongfeng Road, Baimao IndustSE DECISION MADE: 12-JUL-18
Changshu CN 310002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst CSR Shoulder System
Catalyst OrthoScience, Inc. 510(k) NO: K181287(Special)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 12-JUL-18
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Embosphere Microspheres
Biosphere Medical, S.A. 510(k) NO: K181300(Traditional)
ATTN: Alix Fonlladosa PHONE NO : 33 148172529
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 16-JUL-18
Roissy en France FR 95700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InPen Dose Calculator
Companion Medical, Inc. 510(k) NO: K181327(Special)
ATTN: Jasper Benke PHONE NO : 858 5220252
16486 Bernardo Center Drive, # 300SE DECISION MADE: 06-JUL-18
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Pedicle Screw System
Altus Partners, LLC 510(k) NO: K181339(Traditional)
ATTN: Mark Melton PHONE NO : 610 3554156
1340 Enterprise Drive SE DECISION MADE: 24-JUL-18
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JGH1 Bone Graft Substitute
AgNovos Healthcare USA, LLC 510(k) NO: K181342(Traditional)
ATTN: Felipe Aguel PHONE NO : 240 7536408
7301 Calhoun Place, Suite 100 SE DECISION MADE: 19-JUL-18
Rockville MD 20855 510(k) STATEMENT
DEVICE: Image Filing Software NAVIS-EX
Nidek Co., Ltd 510(k) NO: K181345(Traditional)
ATTN: Yoneji Mizuno PHONE NO : 81 533 678901
34-14 Maehama SE DECISION MADE: 19-JUL-18
Hiroishi-cho Gamagori JP 443-003510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA-OCT Spine System
SpineCraft LLC 510(k) NO: K181350(Traditional)
ATTN: Ami Akallal-Asaad PHONE NO : 630 9207300
777 Oakmont Lane SE DECISION MADE: 06-JUL-18
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apex Femoral Nailing System
OrthoXel 510(k) NO: K181375(Traditional)
ATTN: Aisling O'Sullivan PHONE NO : 00 353 212429700
Rubicon Center Cork Institute of TSE DECISION MADE: 17-JUL-18
Bishopstown IE T12 Y275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIETTA 65
Hitachi Healthcare Americas Corpor510(k) NO: K181376(Traditional)
ATTN: Doug Thistlethwaite PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 18-JUL-18
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GuardianTM Burr Hole Cover System
St Jude Medical 510(k) NO: K181382(Abbreviated)
ATTN: Rebecca Brunson PHONE NO : 972 5264658
6901 Preston Road SE DECISION MADE: 20-JUL-18
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Cannula Seal (5-12 mm)
Intuitive Surgical, Inc. 510(k) NO: K181395(Traditional)
ATTN: Cheryl Wu PHONE NO : 408 5236401
1266 Kifer Road SE DECISION MADE: 27-JUL-18
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DV-300 Aspirator
Ding Hwa Co., Ltd. 510(k) NO: K181398(Traditional)
ATTN: Eric Han PHONE NO : 886 2 23451868
No. 121, Sec. 3, Zhongshan Rd. SE DECISION MADE: 23-JUL-18
Dacun TW 51542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREFLY® Pedicle Screw Navigation Guide
Mighty Oak Medical Inc. 510(k) NO: K181399(Traditional)
ATTN: Mark A. Wylie PHONE NO : 720 3989703
750 W. Hampden Avenue, Suite 120 SE DECISION MADE: 24-JUL-18
Englewood CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RxSight Insertion Device
RxSight, Inc. 510(k) NO: K181401(Traditional)
ATTN: Maureen O'Connell PHONE NO : 978 2071245
100 Colombia SE DECISION MADE: 26-JUL-18
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
SPR Therapeutics, Inc. 510(k) NO: K181422(Traditional)
ATTN: Kathryn Stager PHONE NO : 216 3789108
22901 Millcreek Blvd, Suite 110 SE DECISION MADE: 31-JUL-18
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Ureteral Catheter
Cook Incorporated 510(k) NO: K181431(Traditional)
ATTN: Carly Powell PHONE NO : 812 3392235 104913
750 Daniels Way SE DECISION MADE: 30-JUL-18
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proficient® Posterior Cervical Spine System
Spine Wave, Inc. 510(k) NO: K181440(Special)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 30-JUL-18
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT800
Ray Co., Ltd. 510(k) NO: K181452(Traditional)
ATTN: Changhwan Lee PHONE NO : 82 35 6051000
332-7, Samsung 1-ro SE DECISION MADE: 27-JUL-18
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC ALIF Spacer System
Alphatec Spine, Inc. 510(k) NO: K181453(Traditional)
ATTN: Cynthia Adams PHONE NO : 1 760 4946740
5818 El Camino Real SE DECISION MADE: 25-JUL-18
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound, Inc. 510(k) NO: K181485(Third Party - Traditional)
ATTN: Kym Rupp PHONE NO : 425 48771272
22100 Bothell-Everett Hwy SE DECISION MADE: 27-JUL-18
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FilmArray Blood Culture Identification (BCID) Panel
BioFire Diagnostics, LLC 510(k) NO: K181493(Special)
ATTN: Kristen J. Kanack PHONE NO : 801 7366354 1330
515 Colorow Drive SE DECISION MADE: 05-JUL-18
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Republic Spine Dark Star Spinal System
Republic Spine, L.L.C. 510(k) NO: K181495(Special)
ATTN: James Doulgeris PHONE NO : 561 3628094
350 Camino Gardens Blvd. Suite 103SE DECISION MADE: 25-JUL-18
Boca Raton FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI Cocaine Metabolite Assay
Microgenics Corporation 510(k) NO: K181499(Traditional)
ATTN: Emily Chien PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 06-JUL-18
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endorate Valve Sets
Smartdata Suzhou Co., Ltd 510(k) NO: K181509(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 86 512 65983722
4f, Block 7, 198#, Jinshan Rd SE DECISION MADE: 06-JUL-18
Suzhou CN 215011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
PENTAX of America, Inc. 510(k) NO: K181522(Special)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 09-JUL-18
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syneron CO2RE System
Syneron-Candela Corp 510(k) NO: K181523(Special)
ATTN: Sharon Timberlake PHONE NO : 508 3580304
530 Boston Post Road SE DECISION MADE: 11-JUL-18
Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XRpad2 4343 HWC-M Flat Panel Detector
Varex Imaging Corporation 510(k) NO: K181526(Special)
ATTN: Paul Sawicki PHONE NO : 408 4696462
2175 Mission College Blvd. SE DECISION MADE: 03-JUL-18
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Echosens 510(k) NO: K181547(Special)
ATTN: Karine Bonenfant PHONE NO : 33 1 44827856
30 Place d'Italie SE DECISION MADE: 09-JUL-18
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stowe Pedicle Screw System
Black Box Medical 510(k) NO: K181554(Special)
ATTN: Todd Stanaford PHONE NO : 432 3129977
4516 East County Road 45 SE DECISION MADE: 27-JUL-18
Midland TX 79705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA M2 Immunoassay
Phadia AB 510(k) NO: K181556(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 13-JUL-18
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquarius 8600 Digital Radiography Sensor
Biokinemetrics Inc. 510(k) NO: K181565(Special)
ATTN: Steven Kraus PHONE NO : 712 5876193
211 East 4th Street SE DECISION MADE: 13-JUL-18
Carroll IA 51401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Workflow Box
Mirada Medical Ltd. 510(k) NO: K181572(Third Party - Traditional)
ATTN: Gwilym Owen PHONE NO : 44 01865 261410
Oxford Centre for Innovation, NewSE DECISION MADE: 10-JUL-18
Oxford GB ox1 iby 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Uscan
EchoNous, Inc. 510(k) NO: K181574(Third Party - Traditional)
ATTN: Trish Liau PHONE NO : 425 4024044
8310 154th Ave NE Building B, SuitSE DECISION MADE: 10-JUL-18
Redmond VA 98052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
E&E Optics Inc. 510(k) NO: K181579(Traditional)
ATTN: Bonnie Wan PHONE NO : 909 3918330
1795 E. Holt Blvd, Unit 104 SE DECISION MADE: 26-JUL-18
Ontario CA 91761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JGH1 Core Deccompression Procedure Kit
AgNovos Healthcare USA, LLC 510(k) NO: K181585(Traditional)
ATTN: Felipe Aguel PHONE NO : 240 7536408
7301 Calhoun Place, Suite 100 SE DECISION MADE: 20-JUL-18
Rockville MD 20855 510(k) STATEMENT
DEVICE: Tinnitus Sound Generator Module
GN Hearing A/S 510(k) NO: K181586(Special)
ATTN: Lars Hagander PHONE NO : 45 4575 1111
Lautrupbjerg 7 SE DECISION MADE: 13-JUL-18
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathLoc-SI Joint Fusion System
L&K BIOMED Co., Ltd. 510(k) NO: K181600(Special)
ATTN: Jihyeon Seo PHONE NO : 82 2 67171983
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 16-JUL-18
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarifi Imaging System
Modulated Imaging, Inc. 510(k) NO: K181623(Special)
ATTN: David Cuccia PHONE NO : 949 8255070
17151 Gillette Ave SE DECISION MADE: 19-JUL-18
Irvine CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Diagnostic Mobile X-ray System
Samsung Electronics Co., Ltd. 510(k) NO: K181626(Traditional)
ATTN: Chang Soeun PHONE NO : 82 2 21932436
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 20-JUL-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC85A
Samsung Electronics Co., Ltd. 510(k) NO: K181629(Traditional)
ATTN: Noh Jaesang PHONE NO : 82 2 21932444
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 20-JUL-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GR40CW
Samsung Electronics Co., Ltd. 510(k) NO: K181631(Traditional)
ATTN: Noh Jaesang PHONE NO : 82 221 932444
129, Samsung-Ro, Yeongtong-Gu, SE DECISION MADE: 20-JUL-18
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aurora
Sodium Systems, LLC 510(k) NO: K181636(Traditional)
ATTN: Brandon Bachler PHONE NO : 800 8218962
1050 Highland Drive, Suite E SE DECISION MADE: 20-JUL-18
Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bandit guidewire
Vascular Solutions, Inc. 510(k) NO: K181647(Special)
ATTN: Becky Astrup PHONE NO : 763 6575732
6464 Sycamore Court North SE DECISION MADE: 20-JUL-18
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avologi ENEO
Premier North America Inc. 510(k) NO: K181659(Traditional)
ATTN: Yaniv Applicant PHONE NO : 865 44 40618
3301 SW 42nd St SE DECISION MADE: 26-JUL-18
Fort Lauderdale FL 33312-6828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphenix, INFX-8000V/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K181670(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 25-JUL-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 Steam Biological Indicator
STERIS Corporation 510(k) NO: K181686(Special)
ATTN: Tony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 24-JUL-18
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter
Inari Medical 510(k) NO: K181694(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 27-JUL-18
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 16ch Foot/ Ankle SPEEDER
Quality Electrodynamics, LLC 510(k) NO: K181697(Traditional)
ATTN: Eric Yeh PHONE NO : 440 4842940
6655 Beta Drive Suite 100 SE DECISION MADE: 11-JUL-18
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Level 1 Convective Warmer
Smiths Medical ASD, Inc. 510(k) NO: K181699(Third Party - Traditional)
ATTN: Donna M. Semlak PHONE NO : 763 3833076
6000 Nathan Lane SE DECISION MADE: 26-JUL-18
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HardyDisk AST Plazomicin 30ug (PLZ30)
Hardy Diagnostics 510(k) NO: K181700(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222 5752
1430 West McCoy Lane SE DECISION MADE: 10-JUL-18
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: neuromate Gen III
Renishaw Mayfield Sarl 510(k) NO: K181706(Special)
ATTN: Stephane Vinot PHONE NO : 011 33 437238900
31, Rue Ampere SE DECISION MADE: 26-JUL-18
Chassieu FR 69680 510(k) STATEMENT
DEVICE: MTS Plazomicin 0.016-256 µg/mL
Liofilchem s. r. l. 510(k) NO: K181708(Traditional)
ATTN: Fabio Brocco PHONE NO :
Via Scozia zona ind.le SE DECISION MADE: 31-JUL-18
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: San Antonio Stopcock
Cook Incorporated 510(k) NO: K181712(Traditional)
ATTN: James O. Ebot Rnaw PHONE NO : 812 3353575 105648
750 Daniels Way SE DECISION MADE: 26-JUL-18
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epiphany Cardio Server Mobile
Epiphany Healthcare, LLC 510(k) NO: K181720(Third Party - Traditional)
ATTN: Pat White PHONE NO : 336 6177923
3000 E. Boundary Terrace, Suite 2 SE DECISION MADE: 30-JUL-18
Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
Centers for Disease Control and Pr510(k) NO: K181736(Special)
ATTN: Yon Yu PHONE NO : 404 6393046
1600 Clifton Road MS E-51 SE DECISION MADE: 30-JUL-18
Atlanta GA 30329-4027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IceSphere 1.5 CX Cryoablation Needle
Galil Medical Ltd. 510(k) NO: K181741(Special)
ATTN: Stacey Backlund PHONE NO : 267 4143640
Tavor 1 Building, Industrial Park,SE DECISION MADE: 30-JUL-18
Yokneam IL 2069203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Ultrasonic Endoscope
FUJIFILM Corporation 510(k) NO: K181763(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 27-JUL-18
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Hangzhou Clongene Biotech Co.,Ltd.510(k) NO: K181790(Traditional)
ATTN: Zheng Shujian PHONE NO : 86 571 88262120
Building 4, No.20 Longquan Road, YSE DECISION MADE: 26-JUL-18
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultimax-i, DREX-UI80 (V1.60)
Canon Medical Systems Corporation 510(k) NO: K181834(Special)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 19-JUL-18
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadialSeal Introducer Kit
Greatbatch Medical 510(k) NO: K181855(Third Party - Traditional)
ATTN: Phyllis Piet-Hughes PHONE NO : 763 9518184
2300 Berkshire Lane North SE DECISION MADE: 26-JUL-18
Minneapolis MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 242
TOTAL WITH SUMMARIES 232
TOTAL WITH STATEMENTS 10
