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510(k) Data Aggregation

    K Number
    K981724
    Device Name
    O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
    Manufacturer
    MEDTREX, INC.
    Date Cleared
    1998-06-22

    (38 days)

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

    MEDTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.
    Device Description
    The OR Pro 300™ is a full powered electrosurgical generator with separate monopolar and bipolar sections. The monopolar section is designed for cutting and coagulation outputs, is intended for use with a patient return electrode, and is a floating, isolated output. The bipolar section incorporates a separate output from the monopolar output and has independently controlled power. The Bipolar section is a floating isolated output and is intended to be used with bipolar instruments. AC power mains is applied to the generator from a detachable line cord. This power mains voltage is converted to a DC voltage and applied to a single RF amplifier. An RF amplifier utilizes power MOSFETs to convert the DC voltage into a RF energy that is suitable for electrosurgical procedures. The generator is activated by either handswitching or footswitching active accessories. Three different types of CUTTING, Pure, Blend 1 and Blend 2, can be selected by the push buttons on the front panel. Two different types of COAG, Pinpoint and Spray, can also be selected on the front panel. In addition, BIPOLAR COAG is provided through the bipolar output jacks.
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    K Number
    K970130
    Device Name
    HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING
    Manufacturer
    MEDTREX, INC.
    Date Cleared
    1997-03-28

    (72 days)

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

    MEDTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970039
    Device Name
    ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
    Manufacturer
    MEDTREX, INC.
    Date Cleared
    1997-02-26

    (51 days)

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

    MEDTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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