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510(k) Data Aggregation

    K Number
    K214004
    Device Name
    CCBIO ASCPO Needle
    Manufacturer
    CC Biotechnology Corporation
    Date Cleared
    2022-12-13

    (357 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    CC Biotechnology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
    Device Description
    The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe. The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
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