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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 K231633
Device Name Disposable Hemoclip (AF series)
Applicant
Alton (Shanghai) Medical Instruments Co., Ltd.
#24 Bldg. Jinshao Rd. 1688.Baoshan District.
200949. Shanghai. China
Shanghai,  CN 200949
Applicant Contact Vivian Li
Correspondent
Alton (Shanghai) Medical Instruments Co., Ltd.
#24 Bldg. Jinshao Rd.1688.
Baoshan District.
200949 Shanghai,  CN
Correspondent Contact Wei Song
Regulation Number876.4400
Classification Product Code
PKL  
Date Received06/05/2023
Decision Date 01/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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