BEUDAMED
    Product Code: ETK FDA class 1 21 CFR 874.1925

    Tube, Toynbee Diagnostic

    Ear, Nose, Throat

    The Toynbee diagnostic tube is a device used in the assessment of Eustachian tube function, typically by monitoring pressure changes in the middle ear as the patient swallows. It is classified as FDA Class 1, indicating low risk and requiring only general controls. The product code is ETK, regulated under 21 CFR 874.1925 in the Ear, Nose, Throat specialty. No special regulatory flags apply.

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    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    ETK
    Device Class
    FDA class 1
    Regulation Number
    874.1925
    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
    K823774 WILSON EUSTACHIAN TUBAL, SONOGRAPH

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.