BEUDAMED
    Product Code: FXG FDA class 1 21 CFR 878.1800

    Specula Accessories

    General, Plastic Surgery

    Specula accessories are supplementary components used with specula instruments, such as disposable blades, light adapters, or covers, that extend or support the use of the primary speculum device in clinical examinations. They are classified as FDA Class 1 (lowest risk), subject to general controls only, and do not require premarket notification. The product code is FXG, 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
    37
    Registration Numbers
    37
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FXG
    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
    K891589 3MM DISPOSABLE SPECULA

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.