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510(k) Data Aggregation

    K Number
    K231405
    Device Name
    Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
    Date Cleared
    2024-01-18

    (248 days)

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

    Jiangsu Rong Fu Kang Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
    Device Description
    The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile. The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU. The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).
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