K971992 is an FDA 510(k) clearance for the UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026). This device is classified as a Clamp, Penile (Class I - General Controls, product code FHA).
Submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on August 1, 1997, 64 days after receiving the submission on May 29, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5160.
| 510(k) Number | K971992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1997 |
| Decision Date | August 01, 1997 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHA — Clamp, Penile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5160 |