K946296 is an FDA 510(k) clearance for the QUADRA-COIL URETERAL STENT, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 6, 1995, 69 days after receiving the submission on December 27, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K946296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 1994 |
| Decision Date | March 06, 1995 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4620 |