K933260 is an FDA 510(k) clearance for the HELICAL STONE/FLATWIRE STONE BASKETS, a Dislodger, Stone, Basket, Ureteral, Metal (Class II — Special Controls, product code FFL), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on January 11, 1994, 189 days after receiving the submission on July 6, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K933260 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1993 |
| Decision Date | January 11, 1994 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FFL — Dislodger, Stone, Basket, Ureteral, Metal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4680 |