Sphincterotome

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Hangzhou AGS MedTech Co., Ltd.

The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Sphincterotome.

Pre-market Notification Details

Device IDK201121
510k NumberK201121
Device Name:Sphincterotome
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
ContactChunqi Han
CorrespondentChunqi Han
Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2021-02-05

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