K172729 is an FDA 510(k) clearance for the Polypectomy Snare. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 21, 2018, 252 days after receiving the submission on September 11, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K172729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2017 |
| Decision Date | May 21, 2018 |
| Days to Decision | 252 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 |