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510(k) Data Aggregation

    K Number
    K974575
    Device Name
    DAUM ASPIRATIONBIOPSY NEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-06

    (88 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 :

    DAUM ASPIRATIONBIOPSY NEEDLE

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

    The Daum AspirationBiopsy Needle is intended for use in precutaneous or open surgical biopsies, including, but not limited to biopsy of breast, kidney, liver, lymph nodes, and prostate. The Daum AspirationBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.

    Device Description

    Daum AspirationBiopsy Needle

    AI/ML Overview

    This letter is a 510(k) clearance for the Daum AspirationBiopsy Needle. The provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the device is substantially equivalent to legally marketed predicate devices, which means it has been found to have the same intended use and technological characteristics as a device already on the market, or to have different technological characteristics but be as safe and effective as a legally marketed device.

    Therefore, I cannot provide the requested information based on the provided text.

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