Panels › Obstetrics/Gynecology › Product code HEX · Class 2
Colposcope (And Colpomicroscope)
Regulation 884.1630
0510(k)s in 12 months (56 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Wallach Surgical Devices, Inc. | 4 | 0 |
| Dynatech Cryomedical Co. | 3 | 0 |
| Lutech Industries, Inc. | 3 | 0 |
| Sti Medical Systems | 3 | 0 |
| CooperSurgical, Inc. | 2 | 0 |
| Hill-Med, Inc. | 2 | 0 |
| Leisegang Medical, Inc. | 2 | 0 |
| Medgyn Products, Inc. | 2 | 0 |
| Welch Allyn, Inc. | 2 | 0 |
| All-Pro Imaging Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2024 | K233043 | Smart Scope® CX Periwinkle Technologies Pvt., Ltd., IN | HEX |
| May 8, 2019 | K190187 | Gynescope System Illumigyn , Ltd., IL | HEX |
| Nov 27, 2018 | K182764 | Biop Digital Colposcope Biop Medical , Ltd., IL | HEX |
| Sep 21, 2018 | K181034 | Pocket Colposcope System Hadleigh Health Technologies, LLC | HEX |
| May 21, 2017 | K170446 | LT-300 SD Digital Video Colposcope Lutech Industries, Inc. | HEX |
| Dec 19, 2016 | K161871 | EVA (Enhanced Visual Assessment) System Mobileodt , Ltd., IL | HEX |
| Sep 14, 2016 | K160341 | Colposcope System Xuzhou Kernel Medical Equipment Co., Ltd., CN | HEX |
| May 13, 2016 | K160380 | LT-300 HD Lutech Industries, Inc. | HEX |
| Dec 1, 2015 | K151878 | Video Colposcope Edan Instruments, Inc., CN | HEX |
| Dec 18, 2014 | K143119 | LT-300 Video Colposcope Lutech Industries, Inc. | HEX |
| Oct 23, 2014 | K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM CooperSurgical, Inc. | HEX |
| Apr 8, 2014 | K132423 | THE GYNOCULAR Gynius AB, SE | HEX |
| Sep 18, 2013 | K122311 | GC-3000E DIGITAL COLPOSCOPE Shenzhen Goldcare Meditech Co., Ltd. | HEX |
| Jun 12, 2013 | K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE Medgyn Products, Inc. | HEX |
| Apr 8, 2011 | K110147 | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE Sti Medical Systems, LLC | HEX |
| Mar 10, 2011 | K092433 | DYSIS Forth Photonics Hellas SA | HEX |
| Dec 20, 2010 | K090324 | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY Sti Medical Systems | HEX |
| Aug 6, 2010 | K101141 | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 Seiler Precision Microscopes | HEX |
| Jul 9, 2010 | K100595 | ECLERIS MICROSTAR COLPOSCOPE Ecleris USA | HEX |
| Jan 31, 2008 | K072691 | CERVICAL MD, MODEL C10 Sti Medical Systems | HEX |
| Nov 15, 2007 | K073053 | COLPO-MASTER United Products & Instruments, Inc. | HEX |
| Oct 12, 2007 | K070845 | SOUNMED COLOPOSCOPE COLPO-99/99PLUS Sounmed, Inc. | HEX |
| Aug 7, 2006 | K061306 | CO-1000 COLPOSCOPE, MULTIPLE Gynex Corp. | HEX |
| Mar 12, 2004 | K033870 | IMAGE MANAGEMENT SYSTEM Welch Allyn, Inc. | HEX |
| Dec 19, 2003 | K031436 | MEDISCOPE Sometech Corporation | HEX |
| Aug 22, 2003 | K031639 | INTERMED ZOOM COLPOSCOPE Intermed Group, Inc. | HEX |
| Feb 10, 2003 | K021153 | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 Goldway Us, Inc. | HEX |
| Oct 25, 2002 | K021854 | DFV CPG COLPOSCOPE D.F. Vasconcellos S.A. | HEX |
| Jul 25, 2000 | K001314 | MEDSCOPE All-Pro Imaging Corp. | HEX |
| Jun 27, 2000 | K000707 | LEICA COLPOSCOPE Leica Microscopy Systems , Ltd. | HEX |
| Oct 26, 1999 | K992544 | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM Circon Corp. | HEX |
| Oct 19, 1998 | K981958 | LEISEGANG VIDEO COLPOSCOPE Netoptix Corp. | HEX |
| Feb 2, 1998 | K972630 | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM CooperSurgical, Inc. | HEX |
| Apr 22, 1997 | K963593 | IMT LOUPE-COLPOSCOPE Inventive Medical Technology | HEX |
| May 7, 1996 | K955635 | VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND Welch Allyn, Inc. | HEX |
| Apr 25, 1995 | K940094 | COLPOSCOPES AND ACCESSORIES Leisegang Medical, Inc. | HEX |
| Mar 23, 1994 | K932896 | HM-0690 COLPOSCOPE Hill-Med, Inc. | HEX |
| Mar 23, 1994 | K932782 | HM-0660 Hill-Med, Inc. | HEX |
| Apr 27, 1992 | K913365 | ACCUSCOPE(TM) & ACCUSCOPE II(TM) Vineland Medical Products, Inc. | HEX |
| Sep 4, 1990 | K902313 | LM-1Z ZOOM SCOPE Leisegang Medical, Inc. | HEX |
| Jul 27, 1990 | K903213 | ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002 Percutaneous Technologies | HEX |
| Feb 27, 1989 | K890387 | MALLEABLE PLACENTA CURETTE Kinetic Medical Products | HEX |
| Feb 23, 1989 | K884934 | JEDMED KP6 COLPOSCOPE Jedmed Instrument Co. | HEX |
| Mar 14, 1988 | K880195 | GYNESCOPE Medgyn Products, Inc. | HEX |
| Aug 5, 1987 | K871683 | COLPOSTAR V-6 Wallach Surgical Devices, Inc. | HEX |
| Aug 5, 1987 | K871681 | PHOTOSTAR V-8 Wallach Surgical Devices, Inc. | HEX |
| Jun 24, 1987 | K871682 | WALLACH CONVERTIBLE COLPOSCOPE Wallach Surgical Devices, Inc. | HEX |
| Nov 19, 1985 | K853389 | WALLACH ZOOM COLPOSCOPE Wallach Surgical Devices, Inc. | HEX |
| Oct 23, 1985 | K852980 | OCS-2 COLPOSCOPE Olympus Corp. | HEX |
| Jun 16, 1982 | K821616 | CERVISCOPE OPTICAL SYSTEM Fotomedics, Inc. | HEX |
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