K033023 is an FDA 510(k) clearance for the INTERMITTENT URETHRAL CATHETERS. This device is classified as a Catheter, Urological (Class II — Special Controls, product code KOD).
Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on December 23, 2003, 88 days after receiving the submission on September 26, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K033023 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2003 |
| Decision Date | December 23, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |