K160637 is an FDA 510(k) clearance for the Rotatable Snares. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on March 30, 2016, 23 days after receiving the submission on March 7, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K160637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2016 |
| Decision Date | March 30, 2016 |
| Days to Decision | 23 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 |