FHA — Clamp, Penile Class I
FDA product code FHA covers "Clamp, Penile", a Class I medical device regulated under 21 CFR 876.5160. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FHA
- Device Class
- Class I
- Regulation Number
- 876.5160
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974040 | timm research | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | July 14, 1998 |
| K971992 | uromed | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | August 1, 1997 |
| K970308 | mentor urology | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | April 2, 1997 |
| K964580 | nebel | CAP-AID (IMPROVED) | January 10, 1997 |
| K955810 | laborie medical technologies | U-TEX | January 24, 1996 |
| K954959 | nebl | CAP-AID | December 6, 1995 |
| K952841 | apple medical | THE ASSISTANT | August 18, 1995 |
| K896160 | cook urological | WILLIAMS PENILE ANESTHETIC RETAINER | February 16, 1990 |
| K885323 | dacomed | DACOMED EXTERNAL MALE CONTINENCE DEVICE | February 8, 1989 |
| K863227 | cook urological | COOK-VPI CONTINENCE CUFF | February 3, 1987 |
| K780137 | greenwald surgical co | CLAMP, INCONTINENCE, BAUMRUCKER | April 28, 1978 |