The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Hemoclip.
| Device ID | K211787 |
| 510k Number | K211787 |
| Device Name: | Hemoclip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Contact | Yanping Fu |
| Correspondent | Yanping Fu Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2022-03-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMOCLIP 73427982 1287014 Live/Registered |
Edward Weck & Company, Inc. 1983-05-27 |
![]() HEMOCLIP 73031424 1014068 Live/Registered |
EDWARD WECK & COMPANY, INC. 1974-09-09 |