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510(k) Data Aggregation

    K Number
    K973888
    Device Name
    SMARTLOCK SAFETY SYRINGE
    Date Cleared
    1998-06-03

    (232 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INNOVATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A sterile, single-use hypodermic syringe, incorporating a safety mechanism designed to withdraw the needle back into the safety shield after use and lock it in this position. To be used for injecting medications or fluid into the patient by attached cannula or via IV therapy or to draw samples or fluids by the same means.
    Device Description
    The Smartlock™ safety syringe is a sterile, single use hypodermic syringe incorporating an innovative safety mechanism. It is designed to withdraw the needle into the safety shield after use and to lock it in this position. The syringe consists of three parts: a safety shield, a barrel and a plunger. There is no rubber piston. The syringe is packaged fully assembled and no set-up action or pre-use motion is necessary. Needles are attached in the standard luerslip method and can be changed during a procedure, if necessary. The materials used in production are medical grade polypropylene and polyethylene. As the last of the medication is delivered, the plunger rim will disengage the safety clips from the shoulder. As the plunger is retracted (as if to refill), the needle will also retract. The plunger must be retracted fully until a "click" sound is heard and no movement is possible. Disposal is then simple and safe. The functioning of the 3ml, 5ml and 10ml Smartlock ™ Safety Syringes are identical in all respects, save the amount of fluid which can be aspirated.
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