K222421 is an FDA 510(k) clearance for the Sphincterotome, 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 May 3, 2023, 265 days after receiving the submission on August 11, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K222421 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2022 |
| Decision Date | May 03, 2023 |
| Days to Decision | 265 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 |