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

    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

    K Number: K251731 · Decision Dec 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    25
    Review Days
    182

    Basic Information

    Device Name
    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
    K Number
    K251731
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz SE & CO. KG
    Date Received
    June 6, 2025
    Decision Date
    December 5, 2025
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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