Ureterorenoscope System
K-Number: K180367 · 2018-07-03
Decision Date2018-07-03
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ureterorenoscope System is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2018-07-03 under approval number K180367. 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 Ureterorenoscope System?
Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2018-07-03. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K180367.
When was Ureterorenoscope System approved by the FDA?
Ureterorenoscope System received FDA 510(k) clearance on 2018-07-03, under approval number K180367.
What company makes Ureterorenoscope System?
Ureterorenoscope System is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..
What is the FDA product code for Ureterorenoscope System?
The FDA product code for Ureterorenoscope System is FGB.
Other Devices by Shanghai AnQing Medical Instrument Co., Ltd.
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)
K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
Related Devices (Code: FGB)
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K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.
K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EFRichard Wolf Medical Instruments Corporation
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.