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FDA 510(k)

Flexible Video-Choledochoscope System

K-Number: K222261 · 2023-04-20

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2023-04-20
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Choledochoscope System is a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-20 under approval number K222261. 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 System?

Flexible Video-Choledochoscope System is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K222261.

When was Flexible Video-Choledochoscope System approved by the FDA?

Flexible Video-Choledochoscope System received FDA 510(k) clearance on 2023-04-20, under approval number K222261.

What company makes Flexible Video-Choledochoscope System?

Flexible Video-Choledochoscope System is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Flexible Video-Choledochoscope System?

The FDA product code for Flexible Video-Choledochoscope System is FBN.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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

K211686Flexible Video-Choledo-Cysto-Ureteroscope System K222499Disposable Endoscope Valves Kit K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) 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

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