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510(k) Data Aggregation

    K Number
    K032848
    Device Name
    MEDSAFE SYSTEM INSERTER
    Date Cleared
    2004-04-12

    (213 days)

    Product Code
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOLVE TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.
    Device Description
    This device is used in conjunction with a commercially available syringe to aid in the insertion of the syringe needle. The device is constructed of thick walled rigid polycarbonate injection molded components, and a spring, that are permanently assembled within a housing. The devices are provided bulk non-sterile to the user. The user fills a standard syringe and places it in the device. The user positions the device against the injection site. The safety feature is unlocked by rotating the moving carrier. The insertion spring is activated by pressing the device against the skin at the injection site. This spring advances the syringe such that the needle penetrates the skin. The user dispenses the medication by depressing the syringe plunger. Two 'legs' snap over the plunger at the end of the injection stroke to capture the syringe plunger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations.
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