Medical Devices

July 2018 510(k) Clearances

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
                                      

Page Last Updated: 08/20/2018
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