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510(k) Data Aggregation

    K Number
    K982705
    Device Name
    MIDAS TOUCH BIPOLAR FORCEPS
    Manufacturer
    ITI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-09-08

    (36 days)

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

    ITI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar generator in any general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.
    Device Description
    The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps family are similar in design to the predicate devices. They have various tip lengths and configurations, and are available in insulated and non-insulated versions. They are made from a stainless steel or Titanium alloy with a proprietary non-stick coaling. The proximal end has a protective plastic insulator sheath with industry standard clectrosurgery cable connecting pins. Forceps are packaged individually, sold non-sterile, and intended for steam, and EtO sterilization.
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    K Number
    K973234
    Device Name
    MIDAS TOUCH ELECTROSURGICAL ELECTRODE
    Manufacturer
    ITI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-10-27

    (60 days)

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

    ITI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.
    Device Description
    The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the predicate devices. They weigh about 2 grams, and have an industry standard 0.0937-inch (2.38 mm) diameter x 0.825inch (22.22 mm) connector pin, with various tip lengths and configurations. They are made from a stainless steel metal alloy. Some models are available with a stick resistant coating. The transition point between the shaft and the tip has a protective plastic insulator sheath. Electrodes are packaged individually in sealed pouches, sold sterile, and intended for single use.
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