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510(k) Data Aggregation

    K Number
    K013006
    Device Name
    OVUS CAPLESS SAFETY NEEDLE
    Manufacturer
    Date Cleared
    2002-02-06

    (153 days)

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

    OVUS SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OVUS Capless Safety Needle, when used with a standard commercially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent accidental needle sticks.
    Device Description
    The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps protection. The device is made of the following components: (1) a slotted plastic housing, (2) a needle with a tab on the hub that protrudes from the slot in the housing when installed, (3) a spring that fits over the metal needle shaft, (4) a collar bonded to the proximal end of the housing to prevent the needle from sliding out, (5) a locking pin to prevent reuse (tamper-proof version only), and (6) a dust cover for the distal end of the device. The housing has a slot that allows the tab on the needle hub to slide toward the distal end and into the extended position with the needle fully exposed. At each end of the slot there is a short perpendicular slot that serves to lock the needle/tab in either the fully retracted or fully extended position. When extended, the spring is compressed and would tend to retract the needle unless it were locked in the extended position.
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