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510(k) Data Aggregation

    K Number
    K991167
    Device Name
    STERIS SMOKE EVACUATION SYSTEM
    Manufacturer
    STERIS Corporation
    Date Cleared
    1999-06-03

    (57 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STERIS Smoke Evacuation System will be used to evacuate the smoke plume created by electrosurgery, laser surgery, or power tool procedures. Locations for use include the OR, Trauma, Endoscopy and Laparoscopy Suites.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to STERIS Corporation regarding their Smoke Evacuation System. It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request using the provided input. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing STERIS to market it, but it does not detail the technical or clinical studies that would contain the information you are asking for.

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