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510(k) Data Aggregation

    K Number
    K031065
    Device Name
    SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
    Date Cleared
    2003-06-23

    (81 days)

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

    SYRINGEX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary intended use of the Syringex Safety Syringe® is "a hypodermic needle and syringe intended to inject fluid into or withdraw fluid from the body". The secondary intended use is that the sharps safety feature will help to reduce the number of sharps injuries by providing an immediate and mandatory elimination of the sharp by its safe, simple and easy retraction into the barrel of the syringe. The feature will help prevent sharps injuries when using the device for its primary intended use.
    Device Description
    The Syringex Safety Syringe® is a retractable needle safety syringe. The syringe design employs a retractable mechanism that becomes engaged upon injection of the syringes contents. Withdrawal of the plunger retracts the needle into the syringe barrel, holding it securely in place. The plunger stem is broken off to prevent pushing the needle assembly forward. The syringe may be made in all sizes with needle gauges ranging from 18 to 30. The length of the needle is limited only by the length of the barrel in order to contain the needle. Available in lengths from 5/16" to 1 ½".
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