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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

    K Number: K243409 · Decision Nov 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    18
    Applicant Total
    25
    Review Days
    26

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    Basic Information

    Device Name
    KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
    K Number
    K243409
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz SE & CO. KG
    Date Received
    November 1, 2024
    Decision Date
    November 27, 2024
    Product Code
    FBO
    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
    FBO Cystourethroscope

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