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

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

    K Number: K231105 · Decision Oct 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    14
    Review Days
    181

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    Basic Information

    Device Name
    Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
    K Number
    K231105
    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 AnQing Medical Instrument Co., Ltd.
    Date Received
    April 19, 2023
    Decision Date
    October 17, 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

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    Other Clearances by Shanghai AnQing Medical Instrument Co., Ltd.

    K Number Device Name
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