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FDA 510(k)

Biliary Pancreaticobiliary Scope System

K-Number: K241444 · 2025-01-21

ApplicantShenzhen HugeMed Medical Technical Development Co., Ltd.
Decision Date2025-01-21
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Biliary Pancreaticobiliary Scope System is a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2025-01-21 under approval number K241444. 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 Biliary Pancreaticobiliary Scope System?

Biliary Pancreaticobiliary Scope System is a medical device that received FDA 510(k) clearance on 2025-01-21. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K241444.

When was Biliary Pancreaticobiliary Scope System approved by the FDA?

Biliary Pancreaticobiliary Scope System received FDA 510(k) clearance on 2025-01-21, under approval number K241444.

What company makes Biliary Pancreaticobiliary Scope System?

Biliary Pancreaticobiliary Scope System is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..

What is the FDA product code for Biliary Pancreaticobiliary Scope System?

The FDA product code for Biliary Pancreaticobiliary Scope System is FBN.

Related Clinical Trials

NCT07178366 Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) NOT_YET_RECRUITING

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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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