BEUDAMED
    Product Code: MWZ FDA class 1 21 CFR 890.5660

    Expander, Breast, External

    Physical Medicine

    An External Breast Expander is a non-implanted external device applied to the breast externally to apply suction or mechanical force to expand breast tissue, used as an adjunct in breast reconstruction or augmentation procedures without surgery. It is FDA Class 1, subject to general controls only, with product code MWZ under 21 CFR 890.5660 in the Physical Medicine specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MWZ
    Device Class
    FDA class 1
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Review Panel
    SU
    Submission Type
    7

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K770082 SALONMAY BUSTLINE INCREASER