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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K201121
Device Name Sphincterotome
Applicant
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Applicant Contact Chunqi Han
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Chunqi Han
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/27/2020
Decision Date 02/05/2021
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
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