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510(k) Data Aggregation

    K Number
    K140422
    Device Name
    HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
    Manufacturer
    HET SYSTEMS, LLC
    Date Cleared
    2014-06-05

    (107 days)

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

    HET SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HET™ Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
    Device Description
    The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator. The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Systems HET™ Bipolar Electrocautery Forceps and Monitor may be used with any Bipolar Electrosurgical generator in the coagulation mode with an output power set at 10 W and a maximum voltage of 1250v. The monitor displays the temperature at the forceps-tissue interface. The HET" Monitor does not generate RF energy.
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    K Number
    K121085
    Device Name
    HET BIPOLAR LIGATOR SYSTEM
    Manufacturer
    HET SYSTEMS, LLC
    Date Cleared
    2012-11-20

    (224 days)

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

    HET SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids. The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
    Device Description
    The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar Forceps and the HET™ Monitor. The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator. When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
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    K Number
    K110143
    Device Name
    HET BIPOLAR ELECTROCAUTERY FORCEPS
    Manufacturer
    HET SYSTEMS, LLC
    Date Cleared
    2011-06-02

    (135 days)

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

    HET SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
    Device Description
    The HET™ Electrocautery System is comprised of the HET™ Bipolar Electrocautery Forceps and the HET™ Monitor. The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cabel to the bipolar output of an electrosurqical generator. The HET™ Bipolar Forceps has an integrated illumination and a temperature probe. The HET™ Bipolar Forceps can be connected and used with any commercial bi-polar RF generator which is rated less than 50W. The HET™ Monitor is an optional accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the time (in seconds) of RF energy delivery and the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
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