Electrosurgical System (Electrosurgical Generator With Bipolar Polypectomy Snare Combination And Single Use Electrosurgical Knife Combination Accessories)

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 Electrosurgical System (electrosurgical Generator With Bipolar Polypectomy Snare Combination And Single Use Electrosurgical Knife Combination Accessories).

Pre-market Notification Details

Device IDK192342
510k NumberK192342
Device Name:Electrosurgical System (Electrosurgical Generator With Bipolar Polypectomy Snare Combination And Single Use Electrosurgical Knife Combination Accessories)
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  
Subsequent Product CodeFDI
Subsequent Product CodeGEI
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-28
Decision Date2020-05-21

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