K934636 is an FDA 510(k) clearance for the ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR, a Dislodger, Stone, Basket, Ureteral, Metal (Class II — Special Controls, product code FFL), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 25, 1994, 151 days after receiving the submission on September 27, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K934636 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 1993 |
| Decision Date | February 25, 1994 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFL — Dislodger, Stone, Basket, Ureteral, Metal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4680 |