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FDA 510(k)

Flexible Video-Choledo-Cysto-Ureteroscope System

K-Number: K211686 · 2022-02-22

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2022-02-22
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-22 under approval number K211686. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device that received FDA 510(k) clearance on 2022-02-22. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K211686.

When was Flexible Video-Choledo-Cysto-Ureteroscope System approved by the FDA?

Flexible Video-Choledo-Cysto-Ureteroscope System received FDA 510(k) clearance on 2022-02-22, under approval number K211686.

What company makes Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System is FGB.

Related Clinical Trials

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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.

K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System 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: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

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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