BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    MIRA Surgical System

    K Number: DEN230025 · Decision Feb 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    318

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    Basic Information

    Device Name
    MIRA Surgical System
    K Number
    DEN230025
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4962
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Virtual Incision
    Date Received
    April 11, 2023
    Decision Date
    February 23, 2024
    Product Code
    SAB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SAB Table Mounted Miniaturized Electromechanical Surgical System