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510(k) Data Aggregation

    K Number
    K982428
    Device Name
    CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
    Manufacturer
    INNERVISION, INC.
    Date Cleared
    1998-10-09

    (88 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a visible, atraumatic world be advantageous.

    Device Description

    Christoudias Gauze Dissector (Laparoscopic Hand Instrument)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Christoudias Gauze Dissector (Laparoscopic Hand Instrument)". This type of document is a notification of intent to market a device based on substantial equivalence to a legally marketed predicate device.

    It does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related effectiveness studies.

    Therefore, I cannot extract the requested information from the provided text. The document confirms that the FDA reviewed the device and determined it is substantially equivalent, allowing the manufacturer to market it, but it does not detail the specific performance studies that might have been conducted by the manufacturer to establish this equivalence, nor does it refer to AI assistance.

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