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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K252270
Device Name Hemoclip
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 2, 5 And 7, #389 Xingzhong Rd., Linping District
Hangzhou,  CN 311103
Applicant Contact Bingru Wang
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Bldg. 2, 5 And 7, #389 Xingzhong Rd., Linping District
Hangzhou,  CN 311103
Correspondent Contact Bingru Wang
Regulation Number876.4400
Classification Product Code
PKL  
Date Received07/21/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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