BEUDAMED
    Product Code: GBY FDA class 1 21 CFR 878.4200

    Catheter, Eustachian, General & Plastic Surgery

    General, Plastic Surgery

    The Catheter, Eustachian, General and Plastic Surgery (product code GBY) is a catheter used to catheterize the Eustachian tube, which connects the middle ear to the nasopharynx, to allow insufflation of air or delivery of medications for diagnostic or therapeutic purposes. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    GBY
    Device Class
    FDA class 1
    Regulation Number
    878.4200
    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 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.