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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K241704
Device Name Endoscopic Water Pump
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Applicant Contact Yanping Fu
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Bldg. 2, 5 And 7, # 389, Xingzhong Rd.
Linping District, Hangzhou,  CN 311103
Correspondent Contact Yanping Fu
Regulation Number876.1500
Classification Product Code
OCX  
Date Received06/13/2024
Decision Date 03/20/2025
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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