BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Flexible Video-Choledochoscope System

    K Number: K222261 · Decision Apr 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    266

    Basic Information

    Device Name
    Flexible Video-Choledochoscope System
    K Number
    K222261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai SeeGen Photoelectric Technology Co., Ltd
    Date Received
    July 28, 2022
    Decision Date
    April 20, 2023
    Product Code
    FBN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBN Choledochoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FBN), ordered by most recent decision date.

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

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Biliary Pancreaticobiliary Scope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Choledochoscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pusen 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)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Shanghai SeeGen Photoelectric Technology Co., Ltd

    K Number Device Name
    K211686 Flexible Video-Choledo-Cysto-Ureteroscope System