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

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

    K Number: K243535 · Decision Mar 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
    K Number
    K243535
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai SeeGen Photoelectric Technology Co., Ltd.
    Date Received
    November 15, 2024
    Decision Date
    March 7, 2025
    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

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

    K Number Device Name
    K252457 Disposable Distal End Tape Hood
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    K222499 Disposable Endoscope Valves Kit
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