K930483 is an FDA 510(k) clearance for the URETERAL CATHETER, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on July 16, 1993, 168 days after receiving the submission on January 29, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K930483 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | January 29, 1993 |
| Decision Date | July 16, 1993 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |