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510(k) Data Aggregation

    K Number
    K990645
    Device Name
    GALLINI ATRA-CUT NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1999-05-19

    (82 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GALLINI ATRA-CUT NEEDLE

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

    CThe Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Gallini Atra-Cut® Needle. It does NOT contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

    The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market. It refers to a "510(k) notification of intent to market" which would have contained the technical details and performance data, but this specific document (the clearance letter) itself does not include that information.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based only on the text you provided.

    To answer your request, you would need the actual 510(k) submission document or a summary thereof, which typically includes the performance data and comparisons to predicate devices.

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