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510(k) Data Aggregation

    K Number
    K202073
    Device Name
    NeedleSmart Professional (NS Pro)
    Date Cleared
    2021-03-25

    (241 days)

    Product Code
    Regulation Number
    880.6210
    Why did this record match?
    Product Code :

    MTV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeedleSmart Professional (NS Pro) is a needle destruction device that is intended for use by individuals and healthcare professionals to safely destroy 21-25 gauge needles between 0.625 (1/2") inches i.e. approx. 1.6 cm to 3.8 cm. The device is for use in treatment rooms, emergency/trauma rooms, wards, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, and Clinical Laboratories.
    Device Description
    The NeedleSmart Professional (NS Pro) is a needle destruction device that is intended for use by individuals and healthcare professionals to safely destroy needles. It operates using an internal rechargeable Lithiumion battery pack which can be recharged using the power supply (wall charger) that is provided with the unit. The device is not intended to be used while connected to the charger. The NS Pro is activated when the user applies slight downward force on the syringe to insert the needle in the needle aperture disc in the top of the unit. The needle insertion activates a button beneath the insert disc. The needle is then contained by a hard-wearing quartz tube and a current is passed through the tip of the needle, thereby increasing its temperature. Once the needle has been heated to its melting point, it becomes soft and the melted content is collected within a hemispherical electrode. The molten metal gets compressed into a hemispherical 'stub' which is allowed to cool. It is then removed from the device and disposed into a sharps container.
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