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510(k) Data Aggregation

    K Number
    K251874
    Date Cleared
    2025-10-14

    (118 days)

    Product Code
    Regulation Number
    880.5570
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal(800011 800012, 800013) are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for the safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is trained healthcare professionals.

    Device Description

    The PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is injection-molded with high-density polyethylene (HDPE) plastic. Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable, and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white with black text and a black biohazard symbol printed on an orange-red background.

    The container is made of three parts (Base, Lid, and Label) that form a single unit. The red-colored base is conically shaped, and the lid features a clamshell design that snaps in place for a tight seal when the container is full.

    The device is a non-sterile, single-use, disposable sharps infectious waste container designed to contain and hold sharps, such as angiocaths, blood needles, lancets, cap needles, and various-sized syringes. The shape of the container is conical and allows for one-hand disposal of sharps and a clamshell lid for means of closure.

    AI/ML Overview

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