BEUDAMED
    Product Code: FZR FDA class 1 21 CFR 878.4800

    Contractor, Surgical

    General, Plastic Surgery

    The Contractor, Surgical (product code FZR) is a surgical hand instrument used during general or plastic surgery procedures to draw tissue together or apply controlled tension, assisting with wound closure or tissue manipulation. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The device falls under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    0
    Years Active
    —

    Research product code FZR in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    FZR
    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

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.