K946243 is an FDA 510(k) clearance for the CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER. This device is classified as a Device, Incontinence, Urosheath Type, Sterile (Class I - General Controls, product code EXJ).
Submitted by Coloplast A/S (Marietta, US). The FDA issued a Cleared decision on February 13, 1995, 53 days after receiving the submission on December 22, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K946243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1994 |
| Decision Date | February 13, 1995 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXJ — Device, Incontinence, Urosheath Type, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |