K914692 is an FDA 510(k) clearance for the URINARY DIVERSION EVACUATING CATHETER, a Irrigator, Ostomy (Class II — Special Controls, product code EXD), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on July 2, 1992, 258 days after receiving the submission on October 18, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5895.
| 510(k) Number | K914692 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1991 |
| Decision Date | July 02, 1992 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXD — Irrigator, Ostomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5895 |