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510(k) Data Aggregation

    K Number
    K170161
    Device Name
    New Deantronics E Green™ Electrosurgical Monopolar Pencils
    Date Cleared
    2017-03-29

    (70 days)

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

    New Deantronics Taiwan, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Device Description
    The E Green™ Reusable Monopolar Cord is an electrosurgical accessory used with E Green™ Disposable Electrosurgical Pencil. Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. This product is a monopolar, electrosurgical pencil which is used for most open surgeries. The pencil can be divided in two parts, one is a gamma sterilized disposable electrosurgical pencil and another is a reusable cord which needs to be autoclaved by the user before use in a standard operating room environment. The E Green™ Reusable Monopolar Cord is used ONLY in combination with E Green™ Disposable Electrosurgical Pencil. The number of uses of the Reusable Monopolar Cord following steam sterilization is 100 times.
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