K915246 is an FDA 510(k) clearance for the CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH). This device is classified as a Device, Paste-on For Incontinence, Sterile (Class I - General Controls, product code EXI).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on February 5, 1992, 82 days after receiving the submission on November 15, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K915246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1991 |
| Decision Date | February 05, 1992 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXI — Device, Paste-on For Incontinence, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |