HEXClass II
Colposcope (And Colpomicroscope)
21 CFR 884.1630 / Obstetrics/Gynecology
HEX is the FDA product code for Colposcope (And Colpomicroscope), a class II device type, regulated under 21 CFR 884.1630. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HEX
- Device name
- Colposcope (And Colpomicroscope)
- Regulation
- 21 CFR 884.1630
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 56
- Ingested recalls
- 0
Clearances, product code HEX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 1 |
| 1985 | 2 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1992 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code HEX| Applicant | Clearances |
|---|---|
| CooperSurgical, Inc. | 6 |
| Dynatech Cryomedical Co. | 3 |
| Lutech Industries | 3 |
| Sti Medical Systems | 3 |
| Hill-Med, Inc. | 2 |
| Leisegang Medical, Inc. | 2 |
| Medgyn Products, Inc. | 2 |
| Welch Allyn Inc | 2 |
| All-Pro Imaging Corp. | 1 |
| Biop Medical, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.