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510(k) Data Aggregation

    K Number
    K230650
    Device Name
    Monopolar Electrode Surgical Instrument
    Date Cleared
    2023-10-12

    (217 days)

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

    VHMED (Nantong) Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.
    Device Description
    The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.
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