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510(k) Data Aggregation

    K Number
    K012991
    Device Name
    NEPTUNE WASTE MANAGEMENT STSTEM
    Manufacturer
    STRYKER INSTRUMENTS
    Date Cleared
    2001-11-29

    (84 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEPTUNE WASTE MANAGEMENT STSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect surgical fluid waste as well as collect smoke generated by electrosurgical or laser devices.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study details, or how ground truth was established, as it is a regulatory document, not a scientific study report.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document merely states that the "Neptune Waste Management System" is substantially equivalent to legally marketed predicate devices.

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