BEUDAMED
    Product Code: FXF FDA class 1 21 CFR 878.1800

    Speculum, Illuminated

    General, Plastic Surgery

    An illuminated speculum is an examination instrument designed to widen and hold open a body orifice for clinical inspection, incorporating an integrated light source to improve visualization of internal structures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXF, regulated under 21 CFR 878.1800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    FXF
    Device Class
    FDA class 1
    Regulation Number
    878.1800
    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
    K801058 ILLUMINATED SPECULUM

    FEI Numbers

    This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.