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

    KARL STORZ Mediastinoscopes and Instruments

    K Number: K260003 · Decision Mar 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    10
    Applicant Total
    25
    Review Days
    59

    Basic Information

    Device Name
    KARL STORZ Mediastinoscopes and Instruments
    K Number
    K260003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4720
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz SE & CO. KG
    Date Received
    January 2, 2026
    Decision Date
    March 2, 2026
    Product Code
    EWY
    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
    EWY Mediastinoscope, Surgical

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