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FDA 510(k)

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

K-Number: K220159 · 2022-08-26

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2022-08-26
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under approval number K220159. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K220159.

When was Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) approved by the FDA?

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) received FDA 510(k) clearance on 2022-08-26, under approval number K220159.

What company makes Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..

What is the FDA product code for Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

The FDA product code for Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is FGB.

Other Devices by Shanghai AnQing Medical Instrument Co., Ltd.

K180367Ureterorenoscope System K181545Hysteroscope System K201293Ureterorenoscope System K211169Bronchoscope System K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

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Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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