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510(k) Data Aggregation

    K Number
    K112400
    Device Name
    SMARTSHEARS
    Date Cleared
    2011-09-12

    (24 days)

    Product Code
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.
    Device Description
    SmartShears® is a 4-in-1 device used for the removal of bandages, splints, and clothes. The device consists of four configurations which include: the trauma shears, ruler, angle and reflex hammer. Shears: Critical to the development of the SmartShears® for the cutting of bandages, splints or clothes Ruler: The ruler is used for measuring the length of lacerations and the size of entrance/exit wounds, location of a fracture, and rash size. Angle: The angle can be used to measure for angulation of bone fractures. Reflex Hammer: The reflex hammer can be used during a reflex procedure when the cutting blades are closed for testing tendon reflexes and percussing both the abdominal and chest.
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