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510(k) Data Aggregation

    K Number
    K232241
    Device Name
    Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
    Manufacturer
    Betters(Suzhou) Medical Co., Ltd
    Date Cleared
    2023-11-13

    (108 days)

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

    Betters(Suzhou) Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle is not intended for cardiac use.
    Device Description
    Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip. The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator. The Disposable Microwave Ablation Needle is provided sterile, for single use.
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