BEUDAMED
    Product Code: SAB FDA class 2 21 CFR 878.4962

    Table Mounted Miniaturized Electromechanical Surgical System

    General, Plastic Surgery

    A table-mounted miniaturized electromechanical surgical system is a software-controlled electromechanical platform with surgical-table-mounted patient/device interfaces designed to allow qualified surgeons to perform minimally invasive surgical procedures by inserting compact, miniaturized electromechanical arms bearing surgical instruments into body cavities. It is classified as FDA Class II (510(k) required), meaning manufacturers must demonstrate substantial equivalence to a predicate device before marketing. The product code is SAB under regulation 878.4962, in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    SAB
    Device Class
    FDA class 2
    Regulation Number
    878.4962
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN230025 MIRA Surgical System

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.