K201121 is an FDA 510(k) clearance for the Sphincterotome. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 5, 2021, 284 days after receiving the submission on April 27, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K201121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS - Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |