BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    LIBERTY Endovascular Robotic System (LIBERTYOS)

    K Number: K243789 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    269

    Basic Information

    Device Name
    LIBERTY Endovascular Robotic System (LIBERTYOS)
    K Number
    K243789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microbot Medical , Ltd.
    Date Received
    December 9, 2024
    Decision Date
    September 4, 2025
    Product Code
    DXX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXX System, Catheter Control, Steerable

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