K854580 is an FDA 510(k) clearance for the CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II - Special Controls, product code KNX).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on December 13, 1985, 28 days after receiving the submission on November 15, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K854580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1985 |
| Decision Date | December 13, 1985 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |