U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. January 2018 510(k) Clearances
  1. 510(k) Clearances

January 2018 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2018


DEVICE: MiCor A100 Wearable ECG Recorder
MITAC INTERNATIONAL CORP.         510(k) NO: K162665(Traditional)
ATTN: YIHAO  HUANG                PHONE NO : 886 339 62888 
NO. 200, WEN HUA 2ND RD. GUISHAN DSE DECISION MADE: 26-JAN-18
TAOYUAN CITY  TW 33383            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Other-Sonic Transmission Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163023(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 08-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Conductivity Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163024(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 08-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Scanning Gel
Pharmaceutical Innovations Inc.   510(k) NO: K163026(Traditional)
ATTN: Shirley J. Bergman          PHONE NO : 973 2422900 
897 Frelinghuysen Ave.            SE DECISION MADE: 09-JAN-18
Newark NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Free Conductivity Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163027(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 09-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 40-42mm BiPolar Head and 22mm Femoral Head
SIGNATURE ORTHOPAEDICS PTY LTD.   510(k) NO: K163081(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 SIRIUS ROAD                     SE DECISION MADE: 29-JAN-18
LANE COVE  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pelvifine Pelvic Muscle Trainer
Shenzhen Konmed Technology Co., Lt510(k) NO: K163288(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 755 86704558 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 18-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Action Trackstander models TR1816, TR1820, TR2016, and TR2020
Action Manufacturing Inc.         510(k) NO: K163451(Traditional)
ATTN: Alan  Macht                 PHONE NO : 507 5325940 
1105 Lake Rd.                     SE DECISION MADE: 12-JAN-18
Marshall MN  56258                510(k) STATEMENT
                                                    

DEVICE: Kit Boxes and Kit Plates
Nobel Biocare AB                  510(k) NO: K163600(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Vastra Hamngatan 1                SE DECISION MADE: 22-JAN-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 CryoBalloon Ablation System
C2 Therapeutics, Inc.             510(k) NO: K163684(Traditional)
ATTN: Theresa  Brandner-Allen     PHONE NO : 650 5215921 
303 Convention Way, Suite 1       SE DECISION MADE: 23-JAN-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
SHENZHEN WISONIC MEDICAL TECHNOLOG510(k) NO: K163712(Traditional)
ATTN: JIANG  XIAOSAN              PHONE NO : 86 755 86007788 
1ST AND 5TH FLOOR, NO.6 BUILDING, SE DECISION MADE: 02-JAN-18
SHENZHEN  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endotracheal tube; Reinforced Endotracheal tube
Zhanjiang Star Enterprise Co., Ltd510(k) NO: K170234(Traditional)
ATTN: Rongsheng  Tang             PHONE NO : 86 759 2701619 
NO.1, West Jinhua Rd.             SE DECISION MADE: 17-JAN-18
Zhanjiang  TW 524094              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ET Hybrid Abutment
Hiossen Inc.                      510(k) NO: K170421(Traditional)
ATTN: David  Kim                  PHONE NO : 888 6780001 
85 Ben Fairless Dr.               SE DECISION MADE: 11-JAN-18
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiroCam Capsule Endoscope System
IntroMedic Co., Ltd.              510(k) NO: K170438(Traditional)
ATTN: Jinyoung  Lee               PHONE NO : 82 2 8019300 
Suite 1105, 1106, E&C Venture DreaSE DECISION MADE: 30-JAN-18
Seoul  KP 08375                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLOBAL UNITE Platform Shoulder System
DePuy Ireland UC                  510(k) NO: K170748(Traditional)
ATTN: Carol Sandberg Ming         PHONE NO : 508 9776448 
Loughbeg                          SE DECISION MADE: 11-JAN-18
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit F20
ResMed Ltd                        510(k) NO: K170924(Traditional)
ATTN: Johanna  Wright             PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 03-JAN-18
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WAVE Clinical Platform
Excel Medical Electronics, LLC    510(k) NO: K171056(Traditional)
ATTN: Lance  Burton               PHONE NO : 866 5738807 
801 Maplewood Dr. STE-25          SE DECISION MADE: 04-JAN-18
Jupiter FL  33458                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EON Portable Reverse Osmosis Water Purification System
Cantel                            510(k) NO: K171099(Traditional)
ATTN: Mike  Halliday              PHONE NO : 484 9910220 
14550 28th Avenue North           SE DECISION MADE: 05-JAN-18
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
LiNA Medical ApS                  510(k) NO: K171113(Traditional)
ATTN: Natalia  Szychulska         PHONE NO : 48 612 222143 
Formervangen 5                    SE DECISION MADE: 04-JAN-18
Glostrup  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEREC Ortho Software
Dentsply Sirona                   510(k) NO: K171122(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 11-JAN-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aleo BME Liquid Bandage
Aleo BME Inc.                     510(k) NO: K171148(Traditional)
ATTN: Chao  Liu                   PHONE NO : 814 9547381 
200 Innovations Blvd, Ste. 210A   SE DECISION MADE: 12-JAN-18
State College PA  16803           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171207(Traditional)
ATTN: Jeffrey  Wan                PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 11-JAN-18
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Touch Condom with Benzocaine
Thai Nippon Rubber Industry Public510(k) NO: K171213(Traditional)
ATTN: Pisut  Chanwatarungkull (PetPHONE NO : 662 2108888 
1 Charoenrat Road, Thungwatdon, SaSE DECISION MADE: 12-JAN-18
Bangkok  TH 10120                 510(k) STATEMENT
                                                    

DEVICE: Fiji Anchor
SportWelding GmbH                 510(k) NO: K171228(Traditional)
ATTN: Joerg  Mayer                PHONE NO : 41 44 2046121 
Wagistrasse 6                     SE DECISION MADE: 19-JAN-18
Schlieren  CH 8952                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniCap
Respirion, Inc.                   510(k) NO: K171235(Traditional)
ATTN: Ed  Fadel                   PHONE NO : 919 2802534 
101 North Chestnut Street, Suite 2SE DECISION MADE: 04-JAN-18
Winston-Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FMS VUE II Fluid Management and Tissue Debridement System
Medos International SARL          510(k) NO: K171237(Traditional)
ATTN: Tatyana  Korsunsky          PHONE NO : 1 508 8283122 
Chemin-Blanc 38                   SE DECISION MADE: 18-JAN-18
Le Locle Neuchatel  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Epocal Inc.                       510(k) NO: K171247(Traditional)
ATTN: Jennifer  Armstrong         PHONE NO : 613 6883982 2227
2060 Walkley Road                 SE DECISION MADE: 17-JAN-18
Ottawa  CA K1G 3P5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Royal Flush Catheter
Cook Incorporated                 510(k) NO: K171264(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 25-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK® BiMobile(TM) Dual Mobility System
Waldemar Link Gmbh & Co. KG       510(k) NO: K171273(Traditional)
ATTN: Stefanie  Reimers           PHONE NO : 49 405 3995530 
Barkhausenweg 10                  SE DECISION MADE: 19-JAN-18
Hamburg  DE 22339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Bronchoscope Model EB-530P
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171291(Traditional)
ATTN: Shraddha S. More            PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 19-JAN-18
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A7 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171292(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULab Systems Treatment Planning Software
ULab Systems, Inc.                510(k) NO: K171295(Traditional)
ATTN: Charlie  Wen                PHONE NO : 650 8684935 
101 Jefferson Drive, Suite 212A   SE DECISION MADE: 09-JAN-18
Menlo Park CA  95025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AR_N Type Implant System
Biotem Co., Ltd.                  510(k) NO: K171297(Traditional)
ATTN: Hong Koo Yeo                PHONE NO : 82 70 82204934 
57, Sasang-ro , 401 beon-gil , SasSE DECISION MADE: 31-JAN-18
Busan  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A5 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171311(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Builday, Keji 12th Road SoSE DECISION MADE: 12-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FortiCore®
Nanovis LLC                       510(k) NO: K171312(Traditional)
ATTN: Matthew  Hedrick            PHONE NO : 877 9076266 
5865 East State Rd. 14            SE DECISION MADE: 22-JAN-18
Columbia City IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EM-4000 Specular Microscope
Tomey Corporation                 510(k) NO: K171313(Traditional)
ATTN: Tomoko  Watanabe            PHONE NO : 11 815 25815327 
2-11-33 Noritakeshinmachi Nishiku SE DECISION MADE: 19-JAN-18
Nagoya  JP 4510051                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cNeuro cMRI
Combinostics Oy                   510(k) NO: K171328(Traditional)
ATTN: Lennart  Thurfjell          PHONE NO : 46 730 699057 
Hatanpaan valtatie                SE DECISION MADE: 08-JAN-18
Tampere  FI 33100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR4 Laser
Multi Radiance Medical            510(k) NO: K171354(Traditional)
ATTN: Andrey  Godes               PHONE NO : 440 5420761 105___
6521 Davis Industrial Pkwy        SE DECISION MADE: 13-JAN-18
Solon OH  44139                   510(k) STATEMENT
                                                    

DEVICE: CONTEC™ Electrocardiograph
Contec Medical Systems Co., LTD.  510(k) NO: K171360(Traditional)
ATTN: Xueyong  Li                 PHONE NO : 86 355 8015490 
No. 112 QinHuang West Street EconoSE DECISION MADE: 22-JAN-18
QinHuangDao  CN 066012            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Sanrea Healthcare Products Pvt Ltd510(k) NO: K171367(Traditional)
ATTN: Jose  Paul M                PHONE NO : 91 491 2970145 
Plot#P-56, Pearl Road, Kinfra IIT SE DECISION MADE: 26-JAN-18
Palakkad  IN 678 621              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alians Elbow Locking Plating System
Newclip Technics                  510(k) NO: K171372(Special)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 04-JAN-18
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker 90-S Max SERFAS Energy Probe
Stryker                           510(k) NO: K171391(Traditional)
ATTN: Ben  Krebs                  PHONE NO : 408 7542000 
5900 Optical Court                SE DECISION MADE: 26-JAN-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ODFS Pace XL
Odstock Medical Ltd               510(k) NO: K171396(Traditional)
ATTN: Steven  Crook               PHONE NO : 44 1722 439541 
Salisbury District Hospital       SE DECISION MADE: 31-JAN-18
Salisbury  GB SP2 8BJ             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePatch
Braemar Manufacturing, LLC        510(k) NO: K171410(Traditional)
ATTN: Kent  Sayler                PHONE NO : 619 2437500 
3890 Murphy Canyon Road, Suite 100SE DECISION MADE: 04-JAN-18
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRRIS (Infra-Red-Red Intubation System)
A.R Guide In Medical Ltd.         510(k) NO: K171411(Traditional)
ATTN: Ariel  Shrem                PHONE NO : 972 587 622811 
13 Wadi El Haj                    SE DECISION MADE: 12-JAN-18
Nazareth  IL 17111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
Silony Medical GmbH               510(k) NO: K171421(Traditional)
ATTN: Bircan  Yilmaz              PHONE NO : 49 711 78252540 
Leinfelder StraBe 60              SE DECISION MADE: 10-JAN-18
Leinfelden-Echterdingen  DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRONG Dental Handpieces
Saeshin Precision Co., Ltd.       510(k) NO: K171436(Traditional)
ATTN: Choi Jong Woo               PHONE NO : 82 53 5872345 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 05-JAN-18
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatz Support Wire Guide with Apex Curve
Cook Incorporated                 510(k) NO: K171445(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 10-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
Meso Scale Diagnostics, LLC       510(k) NO: K171498(Traditional)
ATTN: Lillian  Quintero           PHONE NO : 240 3142600 
1601 Research Boulevard           SE DECISION MADE: 12-JAN-18
Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uro-V Cystoscope
UroViu Corporation                510(k) NO: K171500(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 3975174 
5337 - 14th Place SE              SE DECISION MADE: 30-JAN-18
Bellevue WA  98006                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Electrocardiograph
Biocare Bio-Medical Equipment Co.,510(k) NO: K171517(Special)
ATTN: Hongbo  Zhong               PHONE NO : 86 0755 36615333 
#16-1, Jinhui Road, Jinsha CommuniSE DECISION MADE: 11-JAN-18
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
Zhejiang kindly Medical Devices Co510(k) NO: K171518(Traditional)
ATTN: Zenghua  Zhang              PHONE NO : 86 577 86872005 
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 05-JAN-18
Wenzhou  CN 325025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
Avantsonic Technology Co., Ltd.   510(k) NO: K171528(Traditional)
ATTN: Cuiling  Wu                 PHONE NO : 86 075 588271976 
No.394, Jingdongfang Avenue BeibeiSE DECISION MADE: 24-JAN-18
Chongqing  CN 400714              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Snorer's Friend
Scope Healthcare Technologies Pty 510(k) NO: K171529(Abbreviated)
ATTN: Ben  Olsen                  PHONE NO : 1 904 8644530 
13/15 King William Road           SE DECISION MADE: 02-JAN-18
Unley  AU 5061                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Navigation Instruments
K2M                               510(k) NO: K171556(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 16-JAN-18
Leesburge VA  20175               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentium Ti-Base
Dentium Co., Ltd.                 510(k) NO: K171622(Traditional)
ATTN: Sangpil  Yoon               PHONE NO : 82 312 072200 
150, Eondong-ro Giheung-gu        SE DECISION MADE: 11-JAN-18
Yongin-si  KR 443-270             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Lumen Ovum Aspiration Needles
Willian A. Cook Australia Pty Ltd 510(k) NO: K171625(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 738 411188 
95 Brandl Street                  SE DECISION MADE: 12-JAN-18
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HBS2 Headless Bone Screw
Stuckenbrock Medizintechnik GmbH  510(k) NO: K171628(Traditional)
ATTN: Fabian  Stuckenbrock        PHONE NO : 49 7461 165880 
Lessingstraße 50                  SE DECISION MADE: 12-JAN-18
Tuttlingen  DE d-78532            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho System
3Shape A/S                        510(k) NO: K171634(Special)
ATTN: Antje  Marquardsen          PHONE NO : 45 702 72620 
Holmens Kanal 7                   SE DECISION MADE: 17-JAN-18
Copenhagen  DK 1060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcatheter and guide-wire system
Suzhou Hengrui Disheng Medical Co.510(k) NO: K171665(Traditional)
ATTN: Jingwen  Li                 PHONE NO : 86 512 66806133 
No. 11 Building, No.8 Jinfeng RoadSE DECISION MADE: 11-JAN-18
Suzhou 215163  CN 215163          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus Cap
GCE Medical Corporation           510(k) NO: K171673(Traditional)
ATTN: Stanley  Chang              PHONE NO : 1 559 4395757 
2723 West Tenaya                  SE DECISION MADE: 19-JAN-18
Fresno CA  93711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angel Align System
Smile Development Corp            510(k) NO: K171674(Traditional)
ATTN: Ian  Kitching               PHONE NO : 408 6211152 
7179 Cherrywood Ct                SE DECISION MADE: 19-JAN-18
Highland CA  92346                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrodes with silver conductive
Shenzhen Konmed Technology Co., Lt510(k) NO: K171721(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 206 6393598 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 05-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrodes with snap / Electrodes with pigtail
Shenzhen Konmed Technology Co., Lt510(k) NO: K171722(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 755 86704558 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 10-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Kronus, Inc.                      510(k) NO: K171731(Traditional)
ATTN: Brian  Deis                 PHONE NO : 208 3774800 
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 19-JAN-18
Star ID  83669                    510(k) STATEMENT
                                                    

DEVICE: ACCLARENT AERA Eustachian Tube Balloon Dilation System
Acclarent, Inc.                   510(k) NO: K171761(Traditional)
ATTN: James Patrick Garvey II     PHONE NO : 949 7898505 
33 Technology Drive               SE DECISION MADE: 16-JAN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecosite Bulk Fill
DMG USA Inc.                      510(k) NO: K171772(Traditional)
ATTN: Gordon  Craig               PHONE NO : 508 2265660 
23 Frank Mossberg Drive           SE DECISION MADE: 31-JAN-18
Attleboro MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Theradome LH80 PRO
Theradome Inc.                    510(k) NO: K171775(Traditional)
ATTN: Tamim  Hamid                PHONE NO : 1 843 8323232 
4900 Hopyard Rd, Ste 100          SE DECISION MADE: 09-JAN-18
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Dental Implant System
Straumann USA, LLC                510(k) NO: K171784(Traditional)
ATTN: Jennifer M. Jackson         PHONE NO : 978 7472509 
60 Minuteman Road                 SE DECISION MADE: 19-JAN-18
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARROW Reverse Porous Glenoid
Fournitures Hospitalieres Industri510(k) NO: K171789(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 33 298 556895 
ZI de Kernevez - 6 rue Nobel      SE DECISION MADE: 23-JAN-18
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Customized Abutment, Elos Prosthetic Screw
Elos Medtech Pinol A/S            510(k) NO: K171799(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 45 482 16469 
Engvej 33                         SE DECISION MADE: 15-JAN-18
Goerloese  DK DK-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Attain Assist CS Access Catheter
Creganna Medical also doing busine510(k) NO: K171819(Traditional)
ATTN: Olivia  Odhiambo            PHONE NO : 353 91 783469 
Parkmore West                     SE DECISION MADE: 04-JAN-18
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReddyPort NIV Access Elbow
SMD Manufacturing, LLC            510(k) NO: K171827(Traditional)
ATTN: Rian  Wendling              PHONE NO : 801 8993036 
2500 South State Street, Suite D22SE DECISION MADE: 19-JAN-18
Salt Lake City UT  84115          510(k) STATEMENT
                                                    

DEVICE: Digital Blood Pressure Monitor-Wrist Style
Shenzhen Combei Technology CO., LT510(k) NO: K171833(Traditional)
ATTN: Huaguang  Meng              PHONE NO : 86 0755 29588956 
Floor 5, Block B, Building G, JinxSE DECISION MADE: 10-JAN-18
Guanlan, Shenzhen  CN 518110      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Irradiation Aesthetic Device
Chongqing Peninsula Medical Techno510(k) NO: K171835(Traditional)
ATTN: Zhang  Sudi                 PHONE NO : 86 150 12578550 
No.2-4, 2F BLK1, Biological and BiSE DECISION MADE: 30-JAN-18
Jiulongpo District  CN 404100     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EarlySense Bed Sensing Unit
EarlySense Ltd.                   510(k) NO: K171836(Traditional)
ATTN: Dalia  Argaman              PHONE NO : 972 3 7522330 106
7 Derech Zeev Jabotinsky          SE DECISION MADE: 04-JAN-18
Ramat Gan  IL 5252007             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sureclear aligners
Emergo Global Consulting, LLC     510(k) NO: K171860(Third Party - Traditional)
ATTN: Stuart R. Goldman           PHONE NO : 512 3279997 
2500 Bee Cave Road, Bldg. 1, SuiteSE DECISION MADE: 05-JAN-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Electrocardiograph
Edan Instruments, Inc.            510(k) NO: K171942(Special)
ATTN: Alice  Yang                 PHONE NO : 86 755 26859216 
#15 Jinhui Road,Jinsha Community KSE DECISION MADE: 24-JAN-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Roadrunner Extra Support Wire Guide
Cook Incorporated                 510(k) NO: K171948(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 05-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLine IV
ClearLine MD                      510(k) NO: K171954(Traditional)
ATTN: Rick  Romeo                 PHONE NO : 781 9336500 
300 TradeCenter, Suite 5400       SE DECISION MADE: 25-JAN-18
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
Mectron SPA                       510(k) NO: K171958(Traditional)
ATTN: Franco  Zunino              PHONE NO : 39 0185 35361 
Via Loreto 15                     SE DECISION MADE: 12-JAN-18
Carasco  IT 16042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoGlo Needle
Smiths Medical ASD, Inc.          510(k) NO: K171968(Traditional)
ATTN: Michael R. Johnson          PHONE NO : 1 763 3833341 
6000 Nathan Lane North            SE DECISION MADE: 25-JAN-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
Lite-On Technology Corp. H.S.P.B. 510(k) NO: K171971(Traditional)
ATTN: John  Lo                    PHONE NO : 886 3 5787722 5804
8, Dusing Road, Hsinchu Science PaSE DECISION MADE: 25-JAN-18
Hsinchu City  TW 30078            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnsoETM
Attune Medical                    510(k) NO: K172029(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 312 7254756 
3440 S. Dearborn St. #215-South   SE DECISION MADE: 05-JAN-18
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
Cook Incorporated                 510(k) NO: K172051(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 1 812 3353575 104371
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 10-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON OVAL V6.0A MRI System
Hitachi Healthcare Americas Corpor510(k) NO: K172110(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 11-JAN-18
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Stryker Corporation               510(k) NO: K172116(Traditional)
ATTN: Kristi  Ashton              PHONE NO : 269 3895929 
4100 E. Milham Avenue             SE DECISION MADE: 25-JAN-18
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Getinge GSS67N Series Steam Sterilizer
Maquet GmbH                       510(k) NO: K172159(Traditional)
ATTN: Holger  Ullrich             PHONE NO : 49 722 29321550 
Kehler Strasse 31                 SE DECISION MADE: 30-JAN-18
Rastatt  DE 76437                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROPEL Device
Propel Orthodontics LLC           510(k) NO: K172164(Traditional)
ATTN: Bryce  Way                  PHONE NO : 408 3945851 
394 South Abbott Ave              SE DECISION MADE: 17-JAN-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulpdent (Activa) Pit and Fissure Sealant with MCP
Pulpdent Corporation              510(k) NO: K172169(Traditional)
ATTN: Kenneth J. Berk             PHONE NO : 1 617 9266666 
80 Oakland Street                 SE DECISION MADE: 05-JAN-18
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guided Growth Plate System Plus
Orthofix Srl                      510(k) NO: K172183(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 09-JAN-18
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
Truemed Group LLC                 510(k) NO: K172189(Traditional)
ATTN: Nina Galeana Rodriguez      PHONE NO : 1 832 4422310 
2002 Timberloch Place Suite 200   SE DECISION MADE: 16-JAN-18
The Woodlands TX  77380           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
Alma Lasers Inc.                  510(k) NO: K172193(Traditional)
ATTN: Rekha  Anand                PHONE NO : 224 3772000 2019
485 Half Day Road Suite # 100     SE DECISION MADE: 09-JAN-18
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYDRASHIFT 2/4 daratumumab, daratumumab Control
Sebia                             510(k) NO: K172195(Traditional)
ATTN: Karen  Anderson             PHONE NO : 770 4463707 3704
1705 Corporate Drive, Suite 400   SE DECISION MADE: 11-JAN-18
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExoToe Staple
ExoToe LLC                        510(k) NO: K172205(Traditional)
ATTN: Avi  Roop                   PHONE NO : 650 8672820 
Po Box 548                        SE DECISION MADE: 11-JAN-18
Grimes IA  50111                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
CTL Medical Corporation           510(k) NO: K172212(Traditional)
ATTN: Tosan  Onosode              PHONE NO : 214 5455820 
4550 Excel Parkway, Suite 300     SE DECISION MADE: 09-JAN-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DTX Studio diagnose
Nobel Biocare AB                  510(k) NO: K172224(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 5030
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 11-JAN-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPI Dental Implant System
MSI France                        510(k) NO: K172240(Traditional)
ATTN: Gerard  Bouna               PHONE NO : 6 5 2129536 
5 Rue des Halles                  SE DECISION MADE: 31-JAN-18
Paris  FR 75001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PulsioFlex Monitoring System
PULSION Medical Systems SE        510(k) NO: K172259(Traditional)
ATTN: Marc  Bergenthal            PHONE NO : 49 89 4599140 
Hans-Riedl-Str. 17                SE DECISION MADE: 18-JAN-18
Feldkirchen  DE 85622             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ipsogen JAK2 RGQ PCR Kit
QIAGEN, Inc.                      510(k) NO: K172287(Traditional)
ATTN: Lindsey  Howard             PHONE NO : 1 240 6867826 
19300 Germantown Road             SE DECISION MADE: 12-JAN-18
Germantown MD  20874              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS
TruAbutment Inc.                  510(k) NO: K172304(Traditional)
ATTN: Brandon  Kim                PHONE NO : 1 714 9561488 
300 South Harbor Blvd #520        SE DECISION MADE: 23-JAN-18
Anaheim CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
STERIS Corporation                510(k) NO: K172319(Traditional)
ATTN: Bill  Brodbeck              PHONE NO : 440 3542600 
5960 Heisley Rd                   SE DECISION MADE: 18-JAN-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew Patient Matched Cutting Blocks
Smith & Nephew, Inc.              510(k) NO: K172336(Special)
ATTN: Brad  Sheals                PHONE NO : 901 3996897 
7135 Goodlett Farms Parkway       SE DECISION MADE: 10-JAN-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instalief
Privi Medical Pte Ltd             510(k) NO: K172358(Traditional)
ATTN: Prusothman M Sinha Raja     PHONE NO : 415 9065188 
79 Ayer Rajah Crescent #05-03     SE DECISION MADE: 10-JAN-18
Singapore  SG 139955              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quickie(r) Q700-UP M
Sunrise Medical (US) LLC          510(k) NO: K172384(Traditional)
ATTN: Nancy J. Gertlar            PHONE NO : 559 2942395 
2842 Business Park Ave            SE DECISION MADE: 16-JAN-18
Fresno CA  93727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARBOR External Fixation System
Globus Medical Inc.               510(k) NO: K172438(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 12-JAN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bruxor
Sleep Specialties, LLC            510(k) NO: K172452(Traditional)
ATTN: James S. Fallon             PHONE NO : 949 7023797 
2565 South Las Vegas Blvd.,Suite #SE DECISION MADE: 11-JAN-18
Las Vegas NV  89109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bone Screws 6.5mm
LimaCorporate S.p.A.              510(k) NO: K172456(Special)
ATTN: Michela  Zanotto            PHONE NO : 39 0432 945511 
Via Nazionale, 52 33038 Villanova SE DECISION MADE: 04-JAN-18
Udine  IT                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Biomet Manufacturing Corp         510(k) NO: K172502(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 2676639 
56 E. Bell Drive                  SE DECISION MADE: 03-JAN-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spineology Navigation Instruments
Spineology Inc.                   510(k) NO: K172518(Traditional)
ATTN: Jacqueline  Hauge           PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 05-JAN-18
Scandia MN  55128                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wiltrom Spinal Fixation System
Wiltrom Corporation Limited       510(k) NO: K172548(Traditional)
ATTN: Yi-Chun  Su                 PHONE NO : 886 3 6107168 
1F., No. 26, Sec. 2, Shengy Rd.   SE DECISION MADE: 12-JAN-18
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE Molding and Occlusion Balloon Catheter
W.L Gore And Associates Inc       510(k) NO: K172567(Traditional)
ATTN: Jeremiah  Andrews           PHONE NO : 623 2345084 
1505 N. Fourth Street             SE DECISION MADE: 31-JAN-18
Flagstaff AZ  86004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
BAROnova, Inc.                    510(k) NO: K172575(Traditional)
ATTN: Lian  Cunningham            PHONE NO : 650 6389796 
1509 Industrial Road              SE DECISION MADE: 18-JAN-18
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System; da Vinci X Surgical System
Intuitive Surgical, Inc.          510(k) NO: K172643(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 31-JAN-18
Sunnyvale AL  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automated ankle brachial pressure index measuring device
Mesi D.O.O.; Mesi, Development of 510(k) NO: K172655(Traditional)
ATTN: Jakob  Susteric             PHONE NO : 386 1 6203487 
Letaliska cesta 3C                SE DECISION MADE: 11-JAN-18
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: reVive Perioral
LED Technologies, Inc.            510(k) NO: K172662(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 4076884 
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 09-JAN-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yamahachi Pink CAD/CAM Disk
Yamahachi Dental Mfg., Co.        510(k) NO: K172683(Traditional)
ATTN: Shogo  Muramatsu            PHONE NO : 81 533 577121 
54-1, Ochigara Nishiura-Cho       SE DECISION MADE: 16-JAN-18
Gamamori-City  JP 443-0105        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORZA® XP Expandable Spacer System
Orthofix Inc.                     510(k) NO: K172696(Traditional)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 19-JAN-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIO-C SEALER
Angelus Industria de Produtos Odon510(k) NO: K172701(Traditional)
ATTN: Paulo Sergio Calixto de OlivPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 04-JAN-18
Londrina  BR 86.031-218           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tec 820, Tec 850
Datex-Ohmeda, Inc.                510(k) NO: K172702(Traditional)
ATTN: Trishia  Mercier            PHONE NO : 608 6958319 
3030 Ohmeda Drive, PO Box 7550    SE DECISION MADE: 04-JAN-18
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108" Length
V2K Medical Inc.                  510(k) NO: K172716(Traditional)
ATTN: Jake  Wolenberg             PHONE NO : 408 9405587 
1221 Innsbruck Drive              SE DECISION MADE: 26-JAN-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh               510(k) NO: K172774(Traditional)
ATTN: Heike  Gustke               PHONE NO : 49 4348 702637 
Prof-Kuentscher-Str. 1-5          SE DECISION MADE: 12-JAN-18
Schoenkirchen  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumilisse IPL Hair Remover
Conair Corporation                510(k) NO: K172791(Traditional)
ATTN: Mike  Cantrell              PHONE NO : 203 9754617 
One Cummings Point Road           SE DECISION MADE: 18-JAN-18
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex Robotic System and Flex Transabdominal Drive
MEDROBOTICS CORPORATION           510(k) NO: K172796(Traditional)
ATTN: Linda J Varroso             PHONE NO : 508 6926460 
475 Paramount Drive               SE DECISION MADE: 18-JAN-18
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann CARES Abutments CoCr
Institut Straumann AG             510(k) NO: K172798(Traditional)
ATTN: Shokoufeh  Khodabandeh      PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 03-JAN-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Besmed Peak Flow Meter
Besmed Health Business Corp.      510(k) NO: K172804(Traditional)
ATTN: Lawrence  Wu                PHONE NO : 886 2 22903959 211
No.5, Lane 116, Wu-Kong 2nd Rd    SE DECISION MADE: 11-JAN-18
Wu-Ku District  TW                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiGer Shark™ System
Choice Spine, LP.                 510(k) NO: K172816(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 26-JAN-18
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symetri Clear
Ormco Corporation                 510(k) NO: K172845(Traditional)
ATTN: Tara  Bonny                 PHONE NO : 909 9625856 
1717 W. Collins Avenue            SE DECISION MADE: 31-JAN-18
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreOp
Epilog                            510(k) NO: K172858(Traditional)
ATTN: Gregor  Strobbe             PHONE NO : 32 484 777651 
Vlasgaardstraat 52                SE DECISION MADE: 08-JAN-18
Ghent  BE 9000                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
ShenZhen Mindray Bio-Medical Elect510(k) NO: K172860(Traditional)
ATTN: Ma  Chao                    PHONE NO : 86 755 81886573 
Mindray Building, Keji 12th Road SSE DECISION MADE: 02-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SedLine Sedation Monitor
Masimo Corporation                510(k) NO: K172890(Traditional)
ATTN: Matthew  Tiacharoen         PHONE NO : 949 2977982 
52 Discovery                      SE DECISION MADE: 26-JAN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
Shenzhen Jiacom Technology Co ., L510(k) NO: K172896(Traditional)
ATTN: Luo  Tianfeng               PHONE NO : 86 755 29015600 
No. A6 Building, Silicon Valley PoSE DECISION MADE: 26-JAN-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Factor II and Factor V Test
Roche Molecular Systems, Inc.     510(k) NO: K172913(Traditional)
ATTN: Pooja  Shah                 PHONE NO : 925 7308886 
4300 Hacienda Drive               SE DECISION MADE: 12-JAN-18
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D APT
Philips Medical Systems Nederland 510(k) NO: K172920(Abbreviated)
ATTN: Jan van de Kerkhof          PHONE NO : 31 61 3300542 
Veenpluis 4-6                     SE DECISION MADE: 22-JAN-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Boston Scientific Corporation     510(k) NO: K172929(Traditional)
ATTN: Daniel  FitzDaniel          PHONE NO : 508 6834156 
100 Boston Scientific Way         SE DECISION MADE: 10-JAN-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini TENS DEVICE (Model: KRES102), TENS &EMS DEVICE (Model: KRES100B)
Shenzhen Conree Technology Co.,Ltd510(k) NO: K172933(Traditional)
ATTN: Rihua  Meng                 PHONE NO : 86 0755 36971650 
Room 210, No 2 Industry Building, SE DECISION MADE: 26-JAN-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embrace
Empatica  Srl                     510(k) NO: K172935(Traditional)
ATTN: Simone  Tognetti            PHONE NO : 0039 334 3078626 
Via Stendhal 36                   SE DECISION MADE: 26-JAN-18
Milano  IT 20144                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
Beta Healthcare Products Pvt.Ltd. 510(k) NO: K172942(Abbreviated)
ATTN: Boney  Moolayil             PHONE NO : 91 484 2413389 
Plot No 21B, Cochin Special EconomSE DECISION MADE: 08-JAN-18
Kochi  IN 682037                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nurture Rest
Neonatal Loving Kare, Inc.        510(k) NO: K172962(Traditional)
ATTN: Nicole  Sawyers             PHONE NO : 814 5904519 
1702 Treasure Lake                SE DECISION MADE: 18-JAN-18
DuBois PA  15801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Up
Y&J BIO Co., Ltd.                 510(k) NO: K172968(Traditional)
ATTN: Kwang Sic Kim               PHONE NO : 82 3400 0325 
No. C-413, Munjeong Hyundai KnowleSE DECISION MADE: 05-JAN-18
Seoul  KR 05836                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Essence 55S Large Monitor System
Shenyang Torch-Bigtide Digital Tec510(k) NO: K172969(Traditional)
ATTN: Fu  Ailing                  PHONE NO : 86 24 88087606 
Shenbei New District NO. 18-6B, YaSE DECISION MADE: 26-JAN-18
Shenyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
Nanova Biomaterials Inc           510(k) NO: K172977(Traditional)
ATTN: Andrew C. Ritts             PHONE NO : 573 8756682 
3806 Mojave Ct                    SE DECISION MADE: 16-JAN-18
Columbia MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme EZ Vitamin D Assay
Diazyme Laboratories              510(k) NO: K172992(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 11-JAN-18
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: OBA-MCP, Orthodontic Bracket Adhesive with MCP
Pulpdent Corporation              510(k) NO: K173020(Traditional)
ATTN: Kenneth J. Berk             PHONE NO : 617 9266666 
80 Oakland Street                 SE DECISION MADE: 17-JAN-18
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
Supersonic Imagine                510(k) NO: K173021(Traditional)
ATTN: Laurence  Hermitte          PHONE NO : 33 442 992424 
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 09-JAN-18
Aix-en-Provence  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigo Workstation Version 2.0
UC-Care Ltd.                      510(k) NO: K173054(Traditional)
ATTN: Hadas  Sheynise             PHONE NO : 972 4 9097427 
Apollo Bldg.,New Industrial Zone, SE DECISION MADE: 16-JAN-18
Yokneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
Fisher and Paykel Healthcare Limit510(k) NO: K173060(Traditional)
ATTN: Ashley  Nguyen              PHONE NO : 64 9 5740123 
15 Maurice Paykel Place           SE DECISION MADE: 25-JAN-18
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
V&Q Manufacturing Corporation     510(k) NO: K173062(Traditional)
ATTN: Jacky  Jin                  PHONE NO : 86 27 87680925 
#B1614 optical valley time square,SE DECISION MADE: 25-JAN-18
Wuhan  CN 430074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: invendoscopy E210 System
invendo medical GmbH              510(k) NO: K173085(Traditional)
ATTN: Oliver v. Ruepprecht        PHONE NO : 49 8233 7449816 
Peterhofstr. 3 b                  SE DECISION MADE: 08-JAN-18
Kissing  DE 86438                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Toshiba Package VSTP-001A
Toshiba Medical Systems Corporatio510(k) NO: K173088(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 31-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
Toshiba Medical Systems Corporatio510(k) NO: K173090(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 11-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Disposable Electronic Thermometer Probe Cover
Medline Industries, Inc.          510(k) NO: K173113(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9492687 
Three Lake Drive                  SE DECISION MADE: 17-JAN-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRI OCT Triton
Topcon Corporation                510(k) NO: K173119(Traditional)
ATTN: Charles  Reisman            PHONE NO : 201 5595283 
75-1 Hasunuma-cho, Itabashi-ku    SE DECISION MADE: 19-JAN-18
Tokyo  JP 174-8580                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Spinal Truss System (CSTS) Interbody Fusion Device
4Web, Inc.                        510(k) NO: K173159(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
2801 Network Blvd.,Suite 620      SE DECISION MADE: 08-JAN-18
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epicardia Anywhere
Medicomp, Inc.                    510(k) NO: K173170(Special)
ATTN: Sean  Marcus                PHONE NO : 321 6760010 
600 Atlantis Rd                   SE DECISION MADE: 10-JAN-18
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUNTOUCH Dental Dressing
Huizhou Foryou Medical Devices Co.510(k) NO: K173196(Traditional)
ATTN: Junfeng  Zhang              PHONE NO : 86 752 5302186 
North Shangxia Rd., Dongjiang Hi-tSE DECISION MADE: 24-JAN-18
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Facet Screw Fixation System
U&i Corporation                   510(k) NO: K173198(Traditional)
ATTN: Yeon-Jung  Choi             PHONE NO : 82 31 8606838 
20, Sandan-ro 76 eon-gil(Rd)      SE DECISION MADE: 03-JAN-18
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Laminoplasty™ Fixation System
Choice Spine, LP                  510(k) NO: K173215(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 19-JAN-18
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAMPYLOBACTER QUIK CHEK
Techlab, Inc.                     510(k) NO: K173217(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 22-JAN-18
Blacksburg VA  24060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAMPYLOBACTER CHEK
Techlab, Inc.                     510(k) NO: K173219(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 22-JAN-18
Blacksburg VA  24060-6358         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swiss LithoClast Trilogy
E.M.S Electro Medical Systems SA  510(k) NO: K173234(Traditional)
ATTN: Sonia  Callegaro            PHONE NO : 41 22 9944700 
Ch de la Vuarpilliere, 31         SE DECISION MADE: 10-JAN-18
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
Scientia Vascular LLC             510(k) NO: K173235(Third Party - Traditional)
ATTN: David  Sabodski             PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 22-JAN-18
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Arthrex PushLock
Arthrex Inc.                      510(k) NO: K173240(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 16-JAN-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
Becton, Dickinson, and Company    510(k) NO: K173252(Traditional)
ATTN: Laura  Stewart              PHONE NO : 410 3164435 
7 Loveton Circle MC 694           SE DECISION MADE: 05-JAN-18
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Carba-R
Cepheid                           510(k) NO: K173263(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 09-JAN-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToggleLoc System
Biomet Inc.                       510(k) NO: K173278(Traditional)
ATTN: Kyle  Ponce                 PHONE NO : 973 2999300 2125
56 East Bell Drive                SE DECISION MADE: 05-JAN-18
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumbar IBF System
Reliance Medical Systems, LLC     510(k) NO: K173283(Special)
ATTN: Bret M. Berry               PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 19-JAN-18
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JOULE SYSTEM
Sciton, Inc                       510(k) NO: K173285(Traditional)
ATTN: Jay M. Patel                PHONE NO : 650 5438348 
925 Commercial Street             SE DECISION MADE: 29-JAN-18
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6440 Ultrasound System
Esaote S.p.A                      510(k) NO: K173291(Traditional)
ATTN: Massimo  Polignano          PHONE NO : 39 055 4229402 
Via Enrico Melen 77               SE DECISION MADE: 12-JAN-18
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Upper Extremity Plates
Smith & Nephew, Inc.              510(k) NO: K173293(Traditional)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 08-JAN-18
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRAGON X SPSL4HC, DRAGON X SPSL8HC
Sedecal SA                        510(k) NO: K173299(Special)
ATTN: MaLuisa  Gomez de Aguero    PHONE NO : 34 91 6290721 
Pelaya, 9 Pol, Pol. Ind. "Rio De JSE DECISION MADE: 26-JAN-18
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioSphere MIS Putty (BioSphere MIS)
Synergy Biomedical, Llc           510(k) NO: K173301(Special)
ATTN: Mark  Borden                PHONE NO : 484 9028141 
100 Springhouse Dr. Suite 108     SE DECISION MADE: 19-JAN-18
Collegeville PA  19426            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ Plate
Zavation Medical Products Llc     510(k) NO: K173306(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 22-JAN-18
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated INFINITY™ Instruments
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K173338(Traditional)
ATTN: Tejas  Patel                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 18-JAN-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cycler Drain Bag Set
Fresenius Medical Care Renal Thera510(k) NO: K173363(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 24-JAN-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, V4.6
Toshiba Medical Systems Corporatio510(k) NO: K173382(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 26-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rex Medical Aspiration Pump
Rex Medical, L.P.                 510(k) NO: K173389(Traditional)
ATTN: Erich  Bressler             PHONE NO : 610 9400665 
555 E. North Ln. Suite 5035       SE DECISION MADE: 30-JAN-18
Conshohocken PA  19428            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc.                      510(k) NO: K173417(Traditional)
ATTN: Nicole  Meredith            PHONE NO : 574 3773718 
P.O. Box 708                      SE DECISION MADE: 30-JAN-18
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeQure® NF and SeQure® Microcatheters
Accurate Medical Therapeutics Ltd.510(k) NO: K173430(Traditional)
ATTN: Eran  Miller                PHONE NO : 972 54 3386871 
21 Habarzel Street                SE DECISION MADE: 26-JAN-18
Tel-Aviv  IL 6971029              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luma Light System
Luma Therapeutics                 510(k) NO: K173436(Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 415 2541148 
10 Rollins Rd Suite 120           SE DECISION MADE: 30-JAN-18
Millbrae CA  94030                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore-S
electroCore, LLC                  510(k) NO: K173442(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 23-JAN-18
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CliniCloud Stethoscope
StethoCloud Pty.Ltd (CliniCloud)  510(k) NO: K173448(Third Party - Traditional)
ATTN: Andrew  Lin                 PHONE NO : 
Level 5, 141 Flinders Lane        SE DECISION MADE: 25-JAN-18
Melbourne VIC  AU 3000            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ViewPoint 6
GE Medical Systems Ultrasound and 510(k) NO: K173456(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
Care Diagnostics, LLC 9900 W InnovSE DECISION MADE: 05-JAN-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panthera Dental Milled Bars
Panthera Dental Inc.              510(k) NO: K173466(Traditional)
ATTN: Martine  Fortin             PHONE NO : 418 5270388 
2035 rue du Haut-Bord             SE DECISION MADE: 26-JAN-18
Quebec City  CA G1n 4n7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 16ch T/R Hand Wrist Coil
Quality Electrodynamics, LLC      510(k) NO: K173469(Traditional)
ATTN: Eric  Yeh                   PHONE NO : 440 4842940 
6655 Beta Drive Suite 100         SE DECISION MADE: 09-JAN-18
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
Shenzhen Mindray Bio-medical Elect510(k) NO: K173471(Traditional)
ATTN: Yang  Zhaohui               PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 08-JAN-18
ShenZhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium® TL Curved Posterior Lumbar Cage
Stryker                           510(k) NO: K173476(Traditional)
ATTN: Nikin  Desai                PHONE NO : 201 7498388 
2 Pearl Court                     SE DECISION MADE: 18-JAN-18
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnSight 3D Extremity System
Carestream Health, Inc.           510(k) NO: K173478(Special)
ATTN: Victoria A. Wheeler         PHONE NO : 585 6278706 
150 Verona Street                 SE DECISION MADE: 19-JAN-18
Rochester NY  14608               510(k) STATEMENT
                                                    

DEVICE: NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
Novo Nordisk Inc.                 510(k) NO: K173479(Traditional)
ATTN: Devraj  Chakravarty         PHONE NO : 609 7865564 
P.O. Box 846                      SE DECISION MADE: 17-JAN-18
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-Y Silicone
Reckitt Benckiser LLC             510(k) NO: K173504(Traditional)
ATTN: Elizabeth  Viguerie         PHONE NO : 973 4042715 
399 Interpace Parkway             SE DECISION MADE: 12-JAN-18
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everest Spinal System
K2M                               510(k) NO: K173508(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 09-JAN-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Cabo ACP (Anterior Cervical Plate) System
SeaSpine Orthopedics Corporation  510(k) NO: K173521(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 24-JAN-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indego(R)
Parker-Hannifin Corporation       510(k) NO: K173530(Traditional)
ATTN: Achilleas  Dorotheou        PHONE NO : 216 8962044 
1390 E. Highland Road             SE DECISION MADE: 31-JAN-18
Macedonia OH  44056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Oncology DL
Arterys Inc.                      510(k) NO: K173542(Traditional)
ATTN: John  Axerio-Cilies         PHONE NO : 650 3917111 
51 Federal Street Suite 305       SE DECISION MADE: 25-JAN-18
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImagenUniversal
Cardiovascular Imaging Technologie510(k) NO: K173547(Traditional)
ATTN: James A. Case               PHONE NO : 816 5312842 
4320 Wornall Road, Suite 114      SE DECISION MADE: 12-JAN-18
Kansas City UT  64111             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
PENTAX of America, Inc.           510(k) NO: K173554(Traditional)
ATTN: James W. Monroe             PHONE NO : 201 5712300 
3 Paragon Drive                   SE DECISION MADE: 19-JAN-18
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K173558(Traditional)
ATTN: Maria  Almesaker            PHONE NO : 46 0 704151007 
Storgatan 11                      SE DECISION MADE: 26-JAN-18
Linkoping  SE 58223               510(k) STATEMENT
                                                    

DEVICE: Barrx SB RFA Endoscopic Catheter
Covidien llc                      510(k) NO: K173559(Special)
ATTN: Saket  Bhatt                PHONE NO : 408 3287357 
15 Hampshire Street               SE DECISION MADE: 18-JAN-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcatheter
Surmodics, Inc.                   510(k) NO: K173560(Traditional)
ATTN: Sherri  Mellingen           PHONE NO : 952 5007081 
9924 W 74th St                    SE DECISION MADE: 12-JAN-18
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
TZ Medical Inc                    510(k) NO: K173563(Traditional)
ATTN: John  Lubisich              PHONE NO : 503 6390282 
17750 SW Upper Boones Ferry Rd #15SE DECISION MADE: 10-JAN-18
Portland OR  97224                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gallant PTCA Dilatation Catheter
Medinol, Ltd.                     510(k) NO: K173581(Traditional)
ATTN: Marina Tikhonov  Demishtein PHONE NO : 972 3 7679000 
Kiryat Atidim, Bldg. 8            SE DECISION MADE: 25-JAN-18
Tel Aviv  IL 6158101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
ThermiGen, L.L.C                  510(k) NO: K173582(Traditional)
ATTN: Suzanne  Cheang             PHONE NO : 214 8880683 
3131 West Royal Lane, Suite 100   SE DECISION MADE: 17-JAN-18
Irving TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
3M Company                        510(k) NO: K173584(Traditional)
ATTN: Hilary B. Hovde             PHONE NO : 651 7360364 
3M Center, Building 275-5W-06     SE DECISION MADE: 22-JAN-18
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Illumeo System
Philips Medical Systems Technologi510(k) NO: K173588(Special)
ATTN: Yoram  Levy                 PHONE NO : 972 4 8310224 
PO Box 325 Building 34            SE DECISION MADE: 12-JAN-18
Haifa  IL 3100202                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Intermittent Urethral Catheters
Teleflex Medical                  510(k) NO: K173596(Traditional)
ATTN: Amanda  Webb                PHONE NO : 919 4338050 
3015 Carrington Mill Blvd         SE DECISION MADE: 29-JAN-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Syringe
Merit Medical Systems, Inc.       510(k) NO: K173601(Abbreviated)
ATTN: Cory  Marsh                 PHONE NO : 801 3163690 
1600 W Merit Parkway              SE DECISION MADE: 31-JAN-18
South Jordan UT  84045            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR240amx, AutoGrid
GE Medical Systems, LLC           510(k) NO: K173602(Traditional)
ATTN: Chris  Paulik               PHONE NO : 262 5482010 
3000 N. Grandview Blvd.           SE DECISION MADE: 12-JAN-18
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIP Arthrodesis System
In2Bones SAS                      510(k) NO: K173616(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 
28 Chemin du Petit Bois           SE DECISION MADE: 19-JAN-18
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS Imaging
Trophy                            510(k) NO: K173622(Traditional)
ATTN: Marie-Pierre  Labat-camy    PHONE NO : 33 1 808500 
4 Rue F. Pelloutier               SE DECISION MADE: 16-JAN-18
Croissy- Beaubourg  FR 77435      510(k) STATEMENT
                                                    

DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc510(k) NO: K173635(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 12-JAN-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Activ Ankle
Newclip Technics                  510(k) NO: K173641(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 16-JAN-18
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaShield System CO2- Fujifilm
United States Endoscopy Group, Inc510(k) NO: K173650(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 05-JAN-18
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Juliet Ti LL
SPINEART                          510(k) NO: K173702(Special)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 03-JAN-18
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
InNeuroCo, Inc                    510(k) NO: K173709(Special)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 26-JAN-18
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kinsa QuickCare Thermometer
KINSA, Inc.                       510(k) NO: K173730(Third Party - Traditional)
ATTN: David  Gal                  PHONE NO : 510 5082700 
535 Mission St, 18th Floor        SE DECISION MADE: 17-JAN-18
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Thermage CPT System and Accessories
Solta Medical                     510(k) NO: K173759(Special)
ATTN: Ken  Nehmer                 PHONE NO : 510 2595299 
11720 North Creek Pkway N. Suite 1SE DECISION MADE: 08-JAN-18
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempus Pro Patient Monitor
Remote Diagnostic Technologies Ltd510(k) NO: K173768(Special)
ATTN: James  Hamlyn               PHONE NO : 44 0 1256362436 
Pavilion C2, Ashwood Park, AshwoodSE DECISION MADE: 10-JAN-18
Basingstoke  GB RG23 8BG          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HI-TORQUE TurnTrac Guide Wire Family
Abbott Vascular                   510(k) NO: K173795(Special)
ATTN: Aniket  Khakhadiya          PHONE NO : 408 8458314 
3200 Lakeside Drive               SE DECISION MADE: 12-JAN-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeGen Medical E3 MIS Pedicle Screw System
Degen Medical                     510(k) NO: K173814(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 29-JAN-18
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Boston Scientific Corporation     510(k) NO: K173820(Special)
ATTN: Mugdha  Dongre              PHONE NO : 510 6242111 
47215 Lakeview Boulevard          SE DECISION MADE: 17-JAN-18
Femont CA  94538                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GU60A & GU60A-65
Samsung Electronics Co.,Ltd.      510(k) NO: K173828(Traditional)
ATTN: Noh  Jaesang                PHONE NO : 82 31 2001764 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 12-JAN-18
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIA Radiation Therapy Management
Varian Medical Systems, Inc.      510(k) NO: K173838(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 17-JAN-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: illumiflow 148 Laser Cap
EGlobal, LLC                      510(k) NO: K173843(Special)
ATTN: Wayne  De Stefano           PHONE NO : 877 3645242 
10115 E Bell Rd Suite 107         SE DECISION MADE: 26-JAN-18
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker AIM Light Source and SafeLight cable
Stryker                           510(k) NO: K173866(Special)
ATTN: Jay  Nayar                  PHONE NO : 408 7542729 
5900 Optical Court                SE DECISION MADE: 18-JAN-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
StelKast, Inc.                    510(k) NO: K173875(Special)
ATTN: Dave  Stumpo                PHONE NO : 724 7312208 
200 Hidden Valley Road            SE DECISION MADE: 19-JAN-18
McMurray PA  15317                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cybird LED Curing Light
DXM Co., Ltd                      510(k) NO: K173876(Special)
ATTN: Seung Hyun  Kim             PHONE NO : 82 31 9098275 
Baekseok-dong, Ilsan technotown 10SE DECISION MADE: 24-JAN-18
Goyang-si  KR 411-360             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreXion3D Excelsior
PreXion Corporation               510(k) NO: K173878(Special)
ATTN: Katsumi  Hayashi            PHONE NO : 81 3 52977551 
1-14-1 Kandasuda-cho              SE DECISION MADE: 19-JAN-18
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Total Knee System
Corin USA Limited                 510(k) NO: K173884(Traditional)
ATTN: Lorraine  Mander            PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 17-JAN-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
Vascular Solutions, Inc.          510(k) NO: K173891(Special)
ATTN: Lisa  Gallatin              PHONE NO : 763 6564300 
6464 Sycamore Court N             SE DECISION MADE: 19-JAN-18
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
Alere Scarborough, Inc.           510(k) NO: K173932(Special)
ATTN: Angela  Drysdale            PHONE NO : 207 4151393 
10 Southgate Road                 SE DECISION MADE: 26-JAN-18
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uDR 780i
Shanghai United Imaging Healthcare510(k) NO: K173953(Traditional)
ATTN: Xin  GAO                    PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 26-JAN-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mic-Key* SF Over-the-Wire Stoma Measuring Device
Halyard Health, Inc.              510(k) NO: K173955(Special)
ATTN: David M Lee                 PHONE NO : 470 4485182 
5405 Windward Parkway             SE DECISION MADE: 26-JAN-18
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip FLEX-V
AtriCure, Inc.                    510(k) NO: K180010(Special)
ATTN: Brittany  Lowe              PHONE NO : 513 7555652 
7555 Innovation  Way              SE DECISION MADE: 31-JAN-18
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Centurion POCT System
Orthofix Inc.                     510(k) NO: K180025(Special)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 22-JAN-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   234                                     
         TOTAL WITH SUMMARIES        224                                     
         TOTAL WITH STATEMENTS        10