Disposable Endoscope Valves System

Endoscope Channel Accessory

Changzhou Endoclean Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Changzhou Endoclean Medical Device Co., Ltd. with the FDA for Disposable Endoscope Valves System.

Pre-market Notification Details

Device IDK221331
510k NumberK221331
Device Name:Disposable Endoscope Valves System
ClassificationEndoscope Channel Accessory
Applicant Changzhou Endoclean Medical Device Co., Ltd. West Side Of 4th Floor, Building E2, No.9 Changyang Road Changzhou,  CN 213149
ContactWang Qi
CorrespondentWang Qi
Changzhou Endoclean Medical Device Co., Ltd. West Side Of 4th Floor, Building E2, No.9 Changyang Road Changzhou,  CN 213149
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-05
Decision Date2022-09-08

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