K950496 is an FDA 510(k) clearance for the SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on March 30, 1995, 52 days after receiving the submission on February 6, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K950496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1995 |
| Decision Date | March 30, 1995 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |