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510(k) Data Aggregation

    K Number
    K212207
    Device Name
    Sterile Hypodermic Syringe for Single Use
    Date Cleared
    2023-03-23

    (616 days)

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

    Shandong Weigao Group Medical Polymer Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.
    Device Description
    The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).
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    K Number
    K212920
    Device Name
    Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
    Date Cleared
    2022-03-11

    (178 days)

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

    Shandong Weigao Group Medical Polymer Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile Safety Syringe with Needle for Single Use is intended for use in the 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 needlesticks. The Sterile Safety Hypodermic Needle for Single Use is 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 needlesticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.
    Device Description
    The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. 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. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes. The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
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