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510(k) Data Aggregation

    K Number
    K974631
    Device Name
    DAUM NEUROBIOPSY NEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-09

    (87 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 NEUROBIOPSY NEEDLE

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

    The Daum NeuroBiopsy Needle is designed for biopsy of the soft tissues in the brain. The Daum NeuroBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for the Daum NeuroBiopsy Needle and an Indications for Use statement. This type of document generally contains regulatory approval information for a medical device but does not include details on acceptance criteria or studies proving device performance. The letter confirms the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it doesn't present data from clinical trials or performance studies.

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

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