K191048 is an FDA 510(k) clearance for the AcuSnare Polypectomy Snare - Duckbill. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on July 18, 2019, 90 days after receiving the submission on April 19, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K191048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2019 |
| Decision Date | July 18, 2019 |
| Days to Decision | 90 days |
| Submission Type | Special |
| 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 |