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FDA 510(k)

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

K-Number: K231105 · 2023-10-17

ApplicantShanghai AnQing Medical Instrument Co., Ltd.
Decision Date2023-10-17
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a medical device manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-10-17 under approval number K231105. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)?

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a medical device that received FDA 510(k) clearance on 2023-10-17. It is manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K231105.

When was Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) approved by the FDA?

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) received FDA 510(k) clearance on 2023-10-17, under approval number K231105.

What company makes Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)?

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is manufactured by Shanghai AnQing Medical Instrument Co., Ltd..

What is the FDA product code for Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)?

The FDA product code for Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is FBN.

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: FBN)

K161147EndoCure Model EUR078AEndocure Technologies, Inc. K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerBoston Scientific Corporation K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd. K222261Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.

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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