FDA Product Code
FDA Product Code HEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1630
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K190187 | Gynescope System | Illumigyn , Ltd. | 2019-05-08 | Traditional | PDF ↗ |
| K182764 | Biop Digital Colposcope | Biop Medical , Ltd. | 2018-11-27 | Traditional | PDF ↗ |
| K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | 2018-09-21 | Traditional | PDF ↗ |
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | 2017-05-21 | Traditional | PDF ↗ |
| K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt , Ltd. | 2016-12-19 | Traditional | PDF ↗ |
| K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 | Traditional | PDF ↗ |
| K160380 | LT-300 HD | Lutech Industries, Inc. | 2016-05-13 | Traditional | PDF ↗ |
| K151878 | Video Colposcope | Edan Instruments, Inc. | 2015-12-01 | Traditional | PDF ↗ |
| K143119 | LT-300 Video Colposcope | Lutech Industries, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | CooperSurgical, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K132423 | THE GYNOCULAR | Gynius AB | 2014-04-08 | Traditional | PDF ↗ |
| K122311 | GC-3000E DIGITAL COLPOSCOPE | Shenzhen Goldcare Meditech Co., Ltd. | 2013-09-18 | Traditional | PDF ↗ |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Medgyn Products, Inc. | 2013-06-12 | Traditional | PDF ↗ |
| K110147 | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | Sti Medical Systems, LLC | 2011-04-08 | Traditional | PDF ↗ |
| K092433 | DYSIS | Forth Photonics Hellas SA | 2011-03-10 | Traditional | PDF ↗ |
| K090324 | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | Sti Medical Systems | 2010-12-20 | Traditional | PDF ↗ |
| K101141 | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | Seiler Precision Microscopes | 2010-08-06 | Traditional | PDF ↗ |
| K100595 | ECLERIS MICROSTAR COLPOSCOPE | Ecleris USA | 2010-07-09 | Traditional | PDF ↗ |
| K072691 | CERVICAL MD, MODEL C10 | Sti Medical Systems | 2008-01-31 | Traditional | PDF ↗ |
| K073053 | COLPO-MASTER | United Products & Instruments, Inc. | 2007-11-15 | Traditional | PDF ↗ |
| K070845 | SOUNMED COLOPOSCOPE COLPO-99/99PLUS | Sounmed, Inc. | 2007-10-12 | Traditional | PDF ↗ |
| K061306 | CO-1000 COLPOSCOPE, MULTIPLE | Gynex Corp. | 2006-08-07 | Traditional | PDF ↗ |
| K033870 | IMAGE MANAGEMENT SYSTEM | Welch Allyn, Inc. | 2004-03-12 | Traditional | PDF ↗ |
| K031436 | MEDISCOPE | Sometech Corporation | 2003-12-19 | Traditional | PDF ↗ |
| K031639 | INTERMED ZOOM COLPOSCOPE | Intermed Group, Inc. | 2003-08-22 | Traditional | PDF ↗ |
| K021153 | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 | Goldway Us, Inc. | 2003-02-10 | Traditional | PDF ↗ |
| K021854 | DFV CPG COLPOSCOPE | D.F. Vasconcellos S.A. | 2002-10-25 | Traditional | PDF ↗ |
| K001314 | MEDSCOPE | All-Pro Imaging Corp. | 2000-07-25 | Traditional | PDF ↗ |
| K000707 | LEICA COLPOSCOPE | Leica Microscopy Systems , Ltd. | 2000-06-27 | Traditional | PDF ↗ |
| K992544 | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM | Circon Corp. | 1999-10-26 | Traditional | PDF ↗ |
| K981958 | LEISEGANG VIDEO COLPOSCOPE | Netoptix Corp. | 1998-10-19 | Traditional | PDF ↗ |
| K972630 | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM | CooperSurgical, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K963593 | IMT LOUPE-COLPOSCOPE | Inventive Medical Technology | 1997-04-22 | Traditional | PDF ↗ |
| K955635 | VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND | Welch Allyn, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K940094 | COLPOSCOPES AND ACCESSORIES | Leisegang Medical, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K932896 | HM-0690 COLPOSCOPE | Hill-Med, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K932782 | HM-0660 | Hill-Med, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K913365 | ACCUSCOPE(TM) & ACCUSCOPE II(TM) | Vineland Medical Products, Inc. | 1992-04-27 | Traditional | PDF ↗ |
| K902313 | LM-1Z ZOOM SCOPE | Leisegang Medical, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K903213 | ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002 | Percutaneous Technologies | 1990-07-27 | Traditional | PDF ↗ |
| K890387 | MALLEABLE PLACENTA CURETTE | Kinetic Medical Products | 1989-02-27 | Traditional | PDF ↗ |
| K884934 | JEDMED KP6 COLPOSCOPE | Jedmed Instrument Co. | 1989-02-23 | Traditional | PDF ↗ |
| K880195 | GYNESCOPE | Medgyn Products, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K871681 | PHOTOSTAR V-8 | Wallach Surgical Devices, Inc. | 1987-08-05 | Traditional | PDF ↗ |
| K871683 | COLPOSTAR V-6 | Wallach Surgical Devices, Inc. | 1987-08-05 | Traditional | PDF ↗ |
| K871682 | WALLACH CONVERTIBLE COLPOSCOPE | Wallach Surgical Devices, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K853389 | WALLACH ZOOM COLPOSCOPE | Wallach Surgical Devices, Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K852980 | OCS-2 COLPOSCOPE | Olympus Corp. | 1985-10-23 | Traditional | PDF ↗ |
| K821616 | CERVISCOPE OPTICAL SYSTEM | Fotomedics, Inc. | 1982-06-16 | Traditional | PDF ↗ |
| K801730 | KRYMED SYSTEM 4001 TILT SCOPE | Cryomedics, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K791279 | KOLPOSKOP KP20005 | Elmed, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K770896 | COLPOSCOPE MODEL II | Dynatech Cryomedical Co. | 1977-06-03 | Traditional | PDF ↗ |
| K770697 | COLPOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-05-20 | Traditional | PDF ↗ |
| K761205 | DYNATECH JD7/JD7P COLPOSCOPE | Dynatech Cryomedical Co. | 1976-12-17 | Traditional | PDF ↗ |
| K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I | Dynatech Cryomedical Co. | 1976-10-20 | Traditional | PDF ↗ |
Product code HEX · Class II · Obstetrics/Gynecology. Data: openFDA.