BEUDAMED
    Product Code: MNB FDA class 3

    Device, Thermal Ablation, Endometrial

    Unknown

    The Endometrial Thermal Ablation Device uses thermal energy, delivered via heated fluid, a balloon, or other thermal applicator, to destroy the endometrial lining of the uterus as a minimally invasive treatment for heavy menstrual bleeding (menorrhagia) in patients who have not responded to medical therapy and do not wish to preserve fertility. As a Class 3 device, it requires Premarket Approval (PMA) due to the risks of thermal injury to adjacent pelvic structures and the irreversible nature of the procedure. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MNB
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OB
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.