BEUDAMED
    Product Code: FTX FDA class 1 21 CFR 878.4800

    Mirror, General & Plastic Surgery

    General, Plastic Surgery

    A general and plastic surgery mirror is a reflective instrument used in operative or clinical settings to provide an indirect view of anatomical areas or the operative field, aiding in surgical planning and intraoperative assessment. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FTX, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FTX
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K870790 REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000

    FEI Numbers

    This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.