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510(k) Data Aggregation

    K Number
    K132120
    Device Name
    WTF SECURA SYRINGE AND NEEDLE
    Manufacturer
    BEIJING WANTEFU MEDICAL APPARATUS CO., LTD.
    Date Cleared
    2013-12-12

    (156 days)

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

    BEIJING WANTEFU MEDICAL APPARATUS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
    Device Description
    The WTF Secura Safety Syringe (with needle) is a sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 1ml, 2.5ml, 3m1, 5ml, and 10ml. and needle sizes: 21-30G. All sizes will be available with a Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a isoamyl stopper, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of needle retracting performance before or after use, allowing for secure encapsulation of the needle point. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe.
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