FHAClass I
Clamp, Penile
21 CFR 876.5160 / Gastroenterology, Urology
FHA is the FDA product code for Clamp, Penile, a class I device type, regulated under 21 CFR 876.5160. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- FHA
- Device name
- Clamp, Penile
- Regulation
- 21 CFR 876.5160
- Device class
- Class I
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 1
Clearances, product code FHA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
Applicants with the most clearances
Product code FHA| Applicant | Clearances |
|---|---|
| Cook Incorporated | 2 |
| CooperSurgical, Inc. | 1 |
| Dacomed Corp. | 1 |
| Greenwald Surgical Co., Inc. | 1 |
| Abbott Medical | 1 |
| Mentor Urology, Inc. | 1 |
| Nebel, Inc. | 1 |
| Nebl, Inc. | 1 |
| Timm Research Co. | 1 |
| Uromed Corp. | 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.