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    K Number
    K192406
    Device Name
    AveCure BT Microwave Ablation System
    Manufacturer
    MedWaves, Inc.
    Date Cleared
    2020-11-25

    (448 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedWaves, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AveCure BT Microwave Ablation System is intended for: - Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. - · Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
    Device Description
    The MedWaves' AveCure BT Microwave Ablation System is comprised of a microwave (915MHz ±13MHz) generator-controller, two antenna sizes mounted on the distal end of probes or catheters of various lengths, and flexibility, and a set of extension cables, one for microwave (MW) transmission and another for information communication between the antenna and the generator. The accessories (probes, catheters and extension-cable set) are supplied sterile and the generator-controller is the durable component of the system and is supplied non-sterile.
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