Disposable Sclerotherapy Needle

Endoscopic Injection Needle, Gastroenterology-urology

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 Disposable Sclerotherapy Needle.

Pre-market Notification Details

Device IDK190032
510k NumberK190032
Device Name:Disposable Sclerotherapy Needle
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant Hangzhou AGS MedTech CO., Ltd Building 5, Building 6, Kangxin Road No.597 Yuhang District Hangzhou,  CN 310000
ContactXiangyong Yu
CorrespondentYangping Fu
Hangzhou AGS MedTech CO., Ltd Building 5, Building 6, Kangxin Road No.597 Yuhang District Hangzhou,  CN 310000
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-07
Decision Date2020-02-27

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