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510(k) Data Aggregation

    K Number
    K981888
    Device Name
    SMOKE-EVAC
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1998-10-15

    (139 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.

    Device Description

    A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.

    AI/ML Overview

    This is a letter from the FDA regarding a 510(k) premarket notification for a device called "Smoke-Evac". The document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

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