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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 K261741
Device Name Hemostatic Clip
Applicant
Anrei Medical (Hz) Co., Ltd.
#3 Ave. 8, Hangzhou Economic Development Area, Hangzhou, Peo
Hangzhou,  CN 310018
Applicant Contact Huibing Yang
Correspondent
Anrei Medical (Hz) Co., Ltd.
No. 3 Ave. 8, Hangzhou Economic Development Area
Hangzhou,  CN 310018
Correspondent Contact Huibing Yang
Regulation Number876.4400
Classification Product Code
PKL  
Date Received05/27/2026
Decision Date 10/02/2026
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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