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

    ENDOFIX EXO

    K Number: K232405 · Decision Apr 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    9
    Applicant Total
    4
    Review Days
    259

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    Basic Information

    Device Name
    ENDOFIX EXO
    K Number
    K232405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aktormed GmbH
    Date Received
    August 10, 2023
    Decision Date
    April 25, 2024
    Product Code
    OCV
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCV Endoscope Holder

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