BEUDAMED
    Product Code: QJA FDA class 3

    Tympanostomy Tube Delivery Product With Drug

    Unknown

    The Tympanostomy Tube Delivery Product With Drug is a combination device intended to place a tympanostomy tube across the tympanic membrane under local anesthesia, combining the mechanical tube insertion function with a drug component. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA), reviewed by the Ear, Nose, and Throat panel, with no regulation number assigned. The product code is QJA, and the device carries an implant flag as the tympanostomy tube is placed through the eardrum. It is not flagged as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QJA
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    EN
    Submission Type
    2

    Device Characteristics

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

    Definition

    Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.