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FDA 510(k)

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

K-Number: K243535 · 2025-03-07

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2025-03-07
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under approval number K243535. 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 Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K243535.

When was Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) approved by the FDA?

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) received FDA 510(k) clearance on 2025-03-07, under approval number K243535.

What company makes Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)?

The FDA product code for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) is FBN.

Other Devices by Shanghai SeeGen Photoelectric Technology Co., Ltd.

K211686Flexible Video-Choledo-Cysto-Ureteroscope System K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) K252457Disposable Distal End Tape Hood

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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