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510(k) Data Aggregation

    K Number
    K992499
    Device Name
    GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1999-08-12

    (17 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 BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE

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

    The Gallini BIOSYSTEM Needle is used for bone biopsy and aspiration procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Gallini BIOSYSTEM® Bone Marrow Aspiration/Biopsy Needle. This document determines substantial equivalence to a predicate device based on its indications for use, but it does not contain any information regarding acceptance criteria or the results of a study demonstrating device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical performance study.

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