Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K-Number: K222737 · 2022-10-05
Decision Date2022-10-05
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-10-05 under approval number K222737. 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: US31E-12-EU, US31E-12-US)?
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) is a medical device that received FDA 510(k) clearance on 2022-10-05. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K222737.
When was Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) approved by the FDA?
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) received FDA 510(k) clearance on 2022-10-05, under approval number K222737.
What company makes Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)?
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..
What is the FDA product code for Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)?
The FDA product code for Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-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)
K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Related Devices (Code: FGB)
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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.