Colposcope (And Colpomicroscope)
FDA product code HEX · Class II (moderate risk) · 21 CFR 884.1630 · Obstetrics/Gynecology
56510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Wallach Surgical Devices, Inc. 4
- Sti Medical Systems 3
- Lutech Industries, Inc. 3
- Dynatech Cryomedical Co. 3
- CooperSurgical, Inc. 2
- Medgyn Products, Inc. 2
- Welch Allyn, Inc. 2
- Leisegang Medical, Inc. 2
- Hill-Med, Inc. 2
- Percutaneous Technologies 1
- Circon Corp. 1
- Netoptix Corp. 1
- Periwinkle Technologies Pvt., Ltd. 1
- Vineland Medical Products, Inc. 1
- Kinetic Medical Products 1
- Jedmed Instrument Co. 1
- Olympus Corp. 1
- Fotomedics, Inc. 1
- Cryomedics, Inc. 1
- Elmed, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233043 | Smart Scope® CXHEX · Traditional | Periwinkle Technologies Pvt., Ltd. | 06/14/2024SE |
| K190187 | Gynescope SystemHEX · Traditional | Illumigyn , Ltd. | 05/08/2019SE |
| K182764 | Biop Digital ColposcopeHEX · Traditional | Biop Medical , Ltd. | 11/27/2018SE |
| K181034 | Pocket Colposcope SystemHEX · Traditional | Hadleigh Health Technologies, LLC | 09/21/2018SE |
| K170446 | LT-300 SD Digital Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 05/21/2017SE |
| K161871 | EVA (Enhanced Visual Assessment) SystemHEX · Traditional | Mobileodt , Ltd. | 12/19/2016SE |
| K160341 | Colposcope SystemHEX · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 09/14/2016SE |
| K160380 | LT-300 HDHEX · Traditional | Lutech Industries, Inc. | 05/13/2016SE |
| K151878 | Video ColposcopeHEX · Traditional | Edan Instruments, Inc. | 12/01/2015SE |
| K143119 | LT-300 Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 12/18/2014SE |
| K140754 | Cooper Surgical Leisegang Colposcope SystemHEX · Traditional | CooperSurgical, Inc. | 10/23/2014SE |
| K132423 | The GynocularHEX · Traditional | Gynius AB | 04/08/2014SE |
| K122311 | GC-3000E Digital ColposcopeHEX · Traditional | Shenzhen Goldcare Meditech Co., Ltd. | 09/18/2013SE |
| K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeHEX · Traditional | Medgyn Products, Inc. | 06/12/2013SE |
| K110147 | Ultrasighthd C31 with Imagesense and Remote Viewer TelemedicineHEX · Traditional | Sti Medical Systems, LLC | 04/08/2011SE |
| K092433 | DysisHEX · Traditional | Forth Photonics Hellas SA | 03/10/2011SE |
| K090324 | Ultrasight HD Digital Colposcopy with Imagesense TechnologyHEX · Traditional | Sti Medical Systems | 12/20/2010SE |
| K101141 | Seiler Colposcope, Models 935, 955 and 985HEX · Traditional | Seiler Precision Microscopes | 08/06/2010SE |
| K100595 | Ecleris Microstar ColposcopeHEX · Traditional | Ecleris USA | 07/09/2010SE |
| K072691 | Cervical MD, Model C10HEX · Traditional | Sti Medical Systems | 01/31/2008SE |
| K073053 | Colpo-MasterHEX · Traditional | United Products & Instruments, Inc. | 11/15/2007SE |
| K070845 | Sounmed Coloposcope COLPO-99/99PLUSHEX · Traditional | Sounmed, Inc. | 10/12/2007SE |
| K061306 | CO-1000 Colposcope, MultipleHEX · Traditional | Gynex Corp. | 08/07/2006SE |
| K033870 | Image Management SystemHEX · Traditional | Welch Allyn, Inc. | 03/12/2004SE |
| K031436 | MediscopeHEX · Traditional | Sometech Corporation | 12/19/2003SE |
| K031639 | Intermed Zoom ColposcopeHEX · Traditional | Intermed Group, Inc. | 08/22/2003SE |
| K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000HEX · Traditional | Goldway Us, Inc. | 02/10/2003SE |
| K021854 | DFV CPG ColposcopeHEX · Traditional | D.F. Vasconcellos S.A. | 10/25/2002SE |
| K001314 | MedscopeHEX · Traditional | All-Pro Imaging Corp. | 07/25/2000SE |
| K000707 | Leica ColposcopeHEX · Traditional | Leica Microscopy Systems , Ltd. | 06/27/2000SE |
| K992544 | Transvaginal Hydro Laparoscopy (THL) SystemHEX · Traditional | Circon Corp. | 10/26/1999SE |
| K981958 | Leisegang Video ColposcopeHEX · Traditional | Netoptix Corp. | 10/19/1998SE |
| K972630 | Coopersurgical Digital Colposcopy SystemHEX · Traditional | CooperSurgical, Inc. | 02/02/1998SE |
| K963593 | Imt Loupe-ColposcopeHEX · Traditional | Inventive Medical Technology | 04/22/1997SE |
| K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandHEX · Traditional | Welch Allyn, Inc. | 05/07/1996SE |
| K940094 | Colposcopes and AccessoriesHEX · Traditional | Leisegang Medical, Inc. | 04/25/1995SE |
| K932896 | HM-0690 ColposcopeHEX · Traditional | Hill-Med, Inc. | 03/23/1994SE |
| K932782 | HM-0660HEX · Traditional | Hill-Med, Inc. | 03/23/1994SE |
| K913365 | Accuscope(Tm) & Accuscope Ii(Tm)HEX · Traditional | Vineland Medical Products, Inc. | 04/27/1992SE |
| K902313 | LM-1Z Zoom ScopeHEX · Traditional | Leisegang Medical, Inc. | 09/04/1990SE |
| K903213 | Arthroscopic Surgical Knives Models 1001 and 1002HEX · Traditional | Percutaneous Technologies | 07/27/1990SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | Kinetic Medical Products | 02/27/1989SE |
| K884934 | Jedmed KP6 ColposcopeHEX · Traditional | Jedmed Instrument Co. | 02/23/1989SE |
| K880195 | GynescopeHEX · Traditional | Medgyn Products, Inc. | 03/14/1988SE |
| K871683 | Colpostar V-6HEX · Traditional | Wallach Surgical Devices, Inc. | 08/05/1987SE |
| K871681 | Photostar V-8HEX · Traditional | Wallach Surgical Devices, Inc. | 08/05/1987SE |
| K871682 | Wallach Convertible ColposcopeHEX · Traditional | Wallach Surgical Devices, Inc. | 06/24/1987SE |
| K853389 | Wallach Zoom ColposcopeHEX · Traditional | Wallach Surgical Devices, Inc. | 11/19/1985SE |
| K852980 | OCS-2 ColposcopeHEX · Traditional | Olympus Corp. | 10/23/1985SE |
| K821616 | Cerviscope Optical SystemHEX · Traditional | Fotomedics, Inc. | 06/16/1982SE |
| K801730 | Krymed System 4001 Tilt ScopeHEX · Traditional | Cryomedics, Inc. | 08/13/1980SE |
| K791279 | Kolposkop KP20005HEX · Traditional | Elmed, Inc. | 09/17/1979SE |
| K770896 | Colposcope Model IIHEX · Traditional | Dynatech Cryomedical Co. | 06/03/1977SE |
| K770697 | Colposcope SystemHEX · Traditional | Richard Wolf Medical Instruments Corp. | 05/20/1977SE |
| K761205 | Dynatech JD7/JD7P ColposcopeHEX · Traditional | Dynatech Cryomedical Co. | 12/17/1976SE |
| K760763 | Colposcope (Dynatech Colposcope-Model IHEX · Traditional | Dynatech Cryomedical Co. | 10/20/1976SE |