K935737 is an FDA 510(k) clearance for the STONE EXTRACTOR, GRASPING FORCEPS. This device is classified as a Dislodger, Stone, Basket, Ureteral, Metal (Class II - Special Controls, product code FFL).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on September 7, 1994, 280 days after receiving the submission on December 1, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K935737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1993 |
| Decision Date | September 07, 1994 |
| Days to Decision | 280 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 |