The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Sphincterotome.
| Device ID | K201121 |
| 510k Number | K201121 |
| Device Name: | Sphincterotome |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Contact | Chunqi Han |
| Correspondent | Chunqi Han Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16959664912123 | K201121 | 000 |
| 16959664912055 | K201121 | 000 |