FDA 510(k) Applications for Medical Device Product Code "HEX"
(Colposcope (And Colpomicroscope))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K001314 | ALL-PRO IMAGING CORP. | MEDSCOPE | 07/25/2000 |
| K182764 | Biop Medical Ltd. | Biop Digital Colposcope | 11/27/2018 |
| K992544 | CIRCON CORP. | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM | 10/26/1999 |
| K140754 | COOPER SURGICAL, INC. | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | 10/23/2014 |
| K972630 | COOPERSURGICAL, INC. | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM | 02/02/1998 |
| K021854 | D.F. VASCONCELLOS S.A. | DFV CPG COLPOSCOPE | 10/25/2002 |
| K100595 | Ecleris USA | ECLERIS MICROSTAR COLPOSCOPE | 07/09/2010 |
| K151878 | EDAN INSTRUMENTS, INC. | Video Colposcope | 12/01/2015 |
| K092433 | FORTH PHOTONICS HELLAS SA | DYSIS | 03/10/2011 |
| K021153 | GOLDWAY US, INC. | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 | 02/10/2003 |
| K061306 | GYNEX CORP. | CO-1000 COLPOSCOPE, MULTIPLE | 08/07/2006 |
| K132423 | GYNIUS AB | THE GYNOCULAR | 04/08/2014 |
| K181034 | Hadleigh Health Technologies, LLC | Pocket Colposcope System | 09/21/2018 |
| K190187 | Illumigyn Ltd. | Gynescope System | 05/08/2019 |
| K031639 | INTERMED GROUP, INC. | INTERMED ZOOM COLPOSCOPE | 08/22/2003 |
| K963593 | INVENTIVE MEDICAL TECHNOLOGY | IMT LOUPE-COLPOSCOPE | 04/22/1997 |
| K000707 | LEICA MICROSCOPY SYSTEMS LTD. | LEICA COLPOSCOPE | 06/27/2000 |
| K160380 | Lutech Industries, Inc. | LT-300 HD | 05/13/2016 |
| K170446 | Lutech Industries, Inc. | LT-300 SD Digital Video Colposcope | 05/21/2017 |
| K143119 | Lutech Industries, Inc. | LT-300 Video Colposcope | 12/18/2014 |
| K122973 | MEDGYN PRODUCTS, INC. | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | 06/12/2013 |
| K161871 | MobileODT Ltd. | EVA (Enhanced Visual Assessment) System | 12/19/2016 |
| K981958 | NETOPTIX CORP. | LEISEGANG VIDEO COLPOSCOPE | 10/19/1998 |
| K101141 | SEILER PRECISION MICROSCOPES | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | 08/06/2010 |
| K122311 | SHENZHEN GOLDCARE MEDITECH CO., LTD. | GC-3000E DIGITAL COLPOSCOPE | 09/18/2013 |
| K031436 | SOMETECH CORPORATION | MEDISCOPE | 12/19/2003 |
| K070845 | SOUNMED, INC. | SOUNMED COLOPOSCOPE COLPO-99/99PLUS | 10/12/2007 |
| K072691 | STI MEDICAL SYSTEMS | CERVICAL MD, MODEL C10 | 01/31/2008 |
| K090324 | STI MEDICAL SYSTEMS | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | 12/20/2010 |
| K110147 | STI MEDICAL SYSTEMS, LLC | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | 04/08/2011 |
| K073053 | UNITED PRODUCTS & INSTRUMENTS, INC. | COLPO-MASTER | 11/15/2007 |
| K033870 | WELCH ALLYN, INC. | IMAGE MANAGEMENT SYSTEM | 03/12/2004 |
| K955635 | WELCH ALLYN, INC. | VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND | 05/07/1996 |
| K160341 | XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD | Colposcope System | 09/14/2016 |
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