Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

Ureteroscope And Accessories, Flexible/rigid

Shanghai AnQing Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Flexible Ureterorenoscope (model: Us31d-12-eu), Flexible Ureterorenoscope (model: Us31d-12-us).

Pre-market Notification Details

Device IDK220159
510k NumberK220159
Device Name:Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant Shanghai AnQing Medical Instrument Co., Ltd. 3 & 4 Floor, No.2 Building, 366 Huiqing Rd East Zhangjiang High-Tech Park Shanghai,  CN 201201
ContactShuwen Fan
CorrespondentShuwen Fan
Shanghai AnQing Medical Instrument Co., Ltd. 3 & 4 Floor, No.2 Building, 366 Huiqing Rd East Zhangjiang High-Tech Park Shanghai,  CN 201201
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-19
Decision Date2022-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970034210611 K220159 000
06970034210383 K220159 000

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