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510(k) Data Aggregation

    K Number
    K170369
    Device Name
    Disposable Electrosurgical Pencils
    Manufacturer
    Cathay Manfacturing Corp.
    Date Cleared
    2018-07-19

    (528 days)

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

    Cathay Manfacturing Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
    Device Description
    The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit). The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad). The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available.
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