K941750 is an FDA 510(k) clearance for the PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES. 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 November 1, 1994, 207 days after receiving the submission on April 8, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K941750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1994 |
| Decision Date | November 01, 1994 |
| Days to Decision | 207 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 |