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

    Symani Surgical System

    K Number: DEN230032 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    346

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    Basic Information

    Device Name
    Symani Surgical System
    K Number
    DEN230032
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4963
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Mmi North America, Inc.
    Date Received
    April 25, 2023
    Decision Date
    April 5, 2024
    Product Code
    SAQ
    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
    SAQ Electromechanical System For Open Microsurgery

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