BEUDAMED
    Product Code: KBI FDA class 1 21 CFR 874.4175

    Bougie, Eustachian

    Ear, Nose, Throat

    A Eustachian bougie is a flexible, tapered instrument used to dilate or probe the Eustachian tube, the canal connecting the middle ear to the nasopharynx, in the diagnosis and treatment of Eustachian tube dysfunction or obstruction. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket clearance. Product code KBI is regulated under 21 CFR 874.4175 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KBI
    Device Class
    FDA class 1
    Regulation Number
    874.4175
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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
    K770959 BOUGIE, FILIFORM, JACKSON

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.