K970308 is an FDA 510(k) clearance for the MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE. This device is classified as a Clamp, Penile (Class I - General Controls, product code FHA).
Submitted by Mentor Urology, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 2, 1997, 65 days after receiving the submission on January 27, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5160.
| 510(k) Number | K970308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1997 |
| Decision Date | April 02, 1997 |
| Days to Decision | 65 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 |