BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Quadsense (Quadsense and Quadsense Pro)

    K Number: K252524 · Decision Sep 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    Quadsense (Quadsense and Quadsense Pro)
    K Number
    K252524
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eventum Orthopaedics, Ltd.
    Date Received
    August 11, 2025
    Decision Date
    September 9, 2025
    Product Code
    ONN
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ONN Intraoperative Orthopedic Joint Assessment Aid

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