K946282 is an FDA 510(k) clearance for the UNIVERSAL URETHRAL CATHETER, a Catheter, Coude (Class II — Special Controls, product code EZC), submitted by Louisville Laboratories, Inc. (Louisville, US). The FDA issued a Cleared decision on March 31, 1995, 94 days after receiving the submission on December 27, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K946282 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 1994 |
| Decision Date | March 31, 1995 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZC — Catheter, Coude |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |