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510(k) Data Aggregation

    K Number
    K252632

    Validate with FDA (Live)

    Date Cleared
    2026-03-02

    (194 days)

    Product Code
    Regulation Number
    878.4400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Microwave Ablation Device is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation Device is not intended for cardiac use.

    Device Description

    The Microwave Ablation Device is intended to be used together with disposable microwave ablation antenna and disposable temperature probe for soft tissue ablation. The Microwave Ablation Device consists of a generator, a disposable temperature probe and a foot switch. The Microwave Ablation Device also contains software that controls and delivers the microwave energy at a working frequency of 2450 MHz.

    Principles of Operation
    When being used with the disposable microwave ablation antenna, the Microwave Ablation Device generates and delivers microwave energy to the disposable microwave ablation antenna after inserting the disposable microwave ablation antenna into the diseased tissue. The microwave acts on the tissue through the disposable microwave ablation antenna, causing charged ions and water molecules in the diseased tissue to oscillate and generate intense heat (similar to a small magnetic needle rotating in a magnetic field). The localized tissue heats up, creating a temperature gradient that decreases from the center outward. When the temperature reaches above 45°C, the proteins within the cells undergo coagulative necrosis, resulting in the destruction of the diseased tissue.

    AI/ML Overview

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