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510(k) Data Aggregation

    K Number
    K253771

    Validate with FDA (Live)

    Device Name
    Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
    Manufacturer
    Nanjing Devin Medical Technology Co., Ltd.
    Date Cleared
    2026-03-02

    (96 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K252632,K232241
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Microwave Ablation Antenna, used in conjunction with the compatible Microwave Ablation Device, is intended for the coagulation (ablation) of soft tissue. The Disposable Microwave Ablation Antenna is not intended for cardiac use.

    Device Description

    The Disposable Microwave Ablation Antenna is intended to be used together with Microwave Ablation Device (K252632) for soft tissue ablation. The Disposable Microwave Ablation Antenna consists of antenna, antenna shaft (temperature measurement component and cooling component), handle and coaxial cable.

    AI/ML Overview

    N/A

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