BEUDAMED
    Product Code: FXE FDA class 1 21 CFR 878.1800

    Speculum, Non-Illuminated

    General, Plastic Surgery

    A non-illuminated speculum is a rigid or semi-rigid instrument used to dilate and hold open body orifices such as the ear canal, nasal passages, or vagina, allowing clinical examination or minor procedures without integrated lighting. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXE, regulated under 21 CFR 878.1800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FXE
    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

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.