BEUDAMED
    Product Code: QGZ FDA class 3

    Electrical Tumor Treatment Fields

    Unknown

    The Electrical Tumor Treatment Fields device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent with chemotherapy, using alternating electric fields to disrupt cancer cell division. It is classified as FDA Class 3, authorized via De Novo (submission type 6), due to its life-sustaining indication in a serious malignancy. The product code is QGZ with no assigned regulation number, reviewed by the Anesthesiology panel. This device carries a life-sustaining/life-supporting flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QGZ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    6

    Device Characteristics

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

    Definition

    The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy.

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.