Single-Use Flexible Cystoscope

Cystoscope And Accessories, Flexible/rigid

Hunan Vathin Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Hunan Vathin Medical Instrument Co., Ltd. with the FDA for Single-use Flexible Cystoscope.

Pre-market Notification Details

Device IDK221580
510k NumberK221580
Device Name:Single-Use Flexible Cystoscope
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan,  CN 411100
ContactDu Jing
CorrespondentDu Jing
Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan,  CN 411100
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-01
Decision Date2022-11-18

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