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510(k) Data Aggregation

    K Number
    K183665
    Device Name
    Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd.
    Date Cleared
    2019-09-06

    (253 days)

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

    Jiangsu Micsafe Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safety Needles: The safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. Sterile Syringe: The sterile syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. Sterile Syringe with Safety Needle: The sterile syringe with safety needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. Sterile Syringe with Needle: The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose. Hypodermic Needles for Single Use: The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.
    Device Description
    (1)Safety Needles: The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. (2)Sterile Syringe: The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle. (3)Sterile Syringe with Safety Needle: This product is intended for manual and single use only. The Sterile Syringe with Safety Needle consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. (4)Sterile Syringe with Needle: The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. (5)Hypodermic Needles for Single Use: The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
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