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510(k) Data Aggregation

    K Number
    K974574
    Device Name
    DAUM NEUROPUNCTURE 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 NEUROPUNCTURE NEEDLE

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

    The Daum NeuroPuncture Needle is designed for use in open and percutaneous sur cal pr of the brain i.e., punctures, biopsies and instillation of substrates. The Doum NeuroPunchia Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.

    Device Description

    Daum NeuroPuncture Needle

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance,
    or details about any studies conducted (sample size, experts, adjudication, MRMC, standalone performance, training set details).
    The document is a US FDA 510(k) clearance letter for the Daum NeuroPuncture Needle, indicating that the device has been
    found substantially equivalent to a predicate device. It defines the device's indications for use but does not contain
    the kind of detailed study results you are asking for.

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