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FDA 510(k)

Choledochoscope System

K-Number: K231497 · 2024-03-06

ApplicantShenzhen HugeMed Medical Technical Development Co., Ltd.
Decision Date2024-03-06
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Choledochoscope System is a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-03-06 under approval number K231497. 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 Choledochoscope System?

Choledochoscope System is a medical device that received FDA 510(k) clearance on 2024-03-06. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K231497.

When was Choledochoscope System approved by the FDA?

Choledochoscope System received FDA 510(k) clearance on 2024-03-06, under approval number K231497.

What company makes Choledochoscope System?

Choledochoscope System is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..

What is the FDA product code for Choledochoscope System?

The FDA product code for Choledochoscope System is FBN.

Other Devices by Shenzhen HugeMed Medical Technical Development Co., Ltd.

K231118Cystoscope System K222910Bronchoscope System K240374Ureterorenoscope System K232435Rhinolaryngoscope system K250695Single-use Ureteral Access Sheath K241444Biliary Pancreaticobiliary Scope System

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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 K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. 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.

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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