BEUDAMED
    Product Code: PNZ FDA class 2 21 CFR 874.4180

    Eustachian Tube Balloon Dilation Device

    Ear, Nose, Throat

    The Eustachian Tube Balloon Dilation Device (product code PNZ) is a Class 2 ear, nose, and throat device intended for use in dilating the cartilaginous portion of the Eustachian tube to treat persistent Eustachian tube dysfunction, regulated under 874.4180. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.

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    510(k)s
    8
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    6
    Years Active
    7

    Basic Information

    Product Code
    PNZ
    Device Class
    FDA class 2
    Regulation Number
    874.4180
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K230742 ACCLARENT AERA Eustachian Tube Dilation System
    K223542 TubaVent Balloon Dilatation System
    K230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System
    K220027 Audion ET dilation system
    K210841 NuVent Eustachian Tube Dilation Balloon
    K171761 ACCLARENT AERA Eustachian Tube Balloon Dilation System
    K163509 XprESS ENT Dilation System
    DEN150056 Acclarent Aera Eustachian Tube Balloon Dilation System

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.