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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K213578
Device Name Balloon Dilatation Catheter
Applicant
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Applicant Contact Jiayuan Zhang
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Jiayuan Zhang
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   KNQ  
Date Received11/10/2021
Decision Date 04/06/2022
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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