BEUDAMED
    Product Code: GAC FDA class 1 21 CFR 878.4800

    Rasp, Surgical, General & Plastic Surgery

    General, Plastic Surgery

    The Rasp, Surgical, General and Plastic Surgery (product code GAC) is a surgical instrument with an abrasive surface used to smooth, shape, or contour bone during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and not requiring a premarket notification submission. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    2
    FEI Numbers
    180
    Registration Numbers
    180
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    GAC
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K884473 RUBIN BONE PLANER W/REPLACEABLE BLADE
    K853601 MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP

    FEI Numbers

    This FDA classification entry is associated with 180 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 180 registration numbers. Click on an entry to view related FDA registrations.