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

    KARL STORZ HOPKINS Telescopes for Urology

    K Number: K243653 · Decision Aug 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    25
    Review Days
    260

    Basic Information

    Device Name
    KARL STORZ HOPKINS Telescopes for Urology
    K Number
    K243653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz SE & CO. KG
    Date Received
    November 26, 2024
    Decision Date
    August 13, 2025
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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