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510(k) Data Aggregation

    K Number
    K060076
    Device Name
    SURGICOUNT SAFETY-SPONGE SYSTEM
    Manufacturer
    SURGICOUNT MEDICAL
    Date Cleared
    2006-03-14

    (63 days)

    Product Code
    LWH
    Regulation Number
    880.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICOUNT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.
    Device Description
    The Safety Sponges include surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique identification label permanently fused to the gauze or fabric. The labels allow the sponges and towels to be individually recognized by a commercially available sight laser imager. The Safety Sponge Counter is a commercially available mobile computer with specialized software designed for mobile data collection. Integrated imaging technology allows capture of the information coded in the unique identification label on the sponges, pads and towels. The computer counts the initial number of sponges opened, and using the custom software program, reports the total sponges used at the end of the procedure or on demand, and compares that number to the original. Individual sponges may be identified as entered into the surgical field but not discarded, so that the surgical field can be explored before surgically closing the patient.
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