Ureterorenoscope System
K-Number: K201293 · 2020-07-24
Decision Date2020-07-24
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 2020-07-24 under approval number K201293. 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 2020-07-24. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K201293.
When was Ureterorenoscope System approved by the FDA?
Ureterorenoscope System received FDA 510(k) clearance on 2020-07-24, under approval number K201293.
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.
K180367Ureterorenoscope System
K181545Hysteroscope 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)
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.