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

    CMOS Video Esophagoscope SSU

    K Number: K192523 · Decision Jan 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    29
    Applicant Total
    25
    Review Days
    133

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    Basic Information

    Device Name
    CMOS Video Esophagoscope SSU
    K Number
    K192523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4710
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz SE & CO. KG
    Date Received
    September 13, 2019
    Decision Date
    January 24, 2020
    Product Code
    EOX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOX Esophagoscope (Flexible Or Rigid)

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