K210406 is an FDA 510(k) clearance for the Bipolar Coagulation Foreceps. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 5, 2021, 237 days after receiving the submission on February 10, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K210406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2021 |
| Decision Date | October 05, 2021 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE - Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |