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510(k) Data Aggregation

    K Number
    K030158
    Device Name
    UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
    Manufacturer
    WALSH MEDICAL DEVICES, INC.
    Date Cleared
    2003-07-17

    (182 days)

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

    WALSH MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CAUTERY HANDLES AND CAUTERY TIPS ARE INTENDED FOR COAGULATING TISSUE OR ARRESTING BLEEDING FROM SMALL VESSELS USING HEAT CREATED BY THE WIRE TIP. INDICATIONS INCLUDE OPHTHALMIC AND GENERAL AND PLASTIC SURGERY PROCEDURES.
    Device Description
    Battery powered Cautery Handles and Cautery Tips to coagulate tissue or arrest bleeding from small vessels using heat created by the wire tip during Ophthalmic, General and Plastic Surgery and Vasectomy procedures.
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