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510(k) Data Aggregation

    K Number
    K002341
    Device Name
    THERMAL CAUTERY UNIT, MODEL 150
    Manufacturer
    GEIGER MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2000-10-23

    (83 days)

    Product Code
    HQO
    Regulation Number
    886.4115
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEIGER MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001029
    Device Name
    GEIGER NEEDLE ADAPTER, MODEL 406
    Manufacturer
    GEIGER MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2000-05-23

    (54 days)

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

    GEIGER MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994075
    Device Name
    GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
    Manufacturer
    GEIGER MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-12-27

    (25 days)

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

    GEIGER MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Utilized for basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation.
    Device Description
    The Geiger Disposable Electrosurgical Electrode is a non-sterile, disposable, electrosurgical electrode, designed to be used to deliver electrosurgical current generated by an electrosurgical generator.
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    K Number
    K992149
    Device Name
    GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
    Manufacturer
    GEIGER MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-08-19

    (56 days)

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

    GEIGER MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Geiger Electrosurgical Handpiece Sheath is intended to be placed over an electrosurgical handpiece and act as a non-sterile barrier.
    Device Description
    The Geiger Electrosurgical Handpiece Sheath is a non-sterile, clear plastic, disposable, electrosurgical handpiece cover, designed to be used over an electrosurgical handpiece to limit contamination.
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    K Number
    K983852
    Device Name
    BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429
    Manufacturer
    GEIGER MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-01-28

    (90 days)

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

    GEIGER MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Utilized for basic electrosurgical procedures such as cutting, blended cutting, coagulation, fulguration, or desiccation.
    Device Description
    The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.
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