K012581 is an FDA 510(k) clearance for the REPROCESSED STONE RETRIEVAL BASKETS. This device is classified as a Dislodger, Stone, Basket, Ureteral, Metal (Class II - Special Controls, product code FFL).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 14, 2002, 189 days after receiving the submission on August 9, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K012581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2001 |
| Decision Date | February 14, 2002 |
| Days to Decision | 189 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 |