LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990278
    Device Name
    DAUM NEUROCUT NEUROBIOPSYNEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1999-03-30

    (61 days)

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

    DAUM NEUROCUT NEUROBIOPSYNEEDLE

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

    The Daum NeuroCut NeuroBiopsyNeedle is designed for biopsy of the soft tissue in the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle.

    Device Description

    Daum NeuroCut NeuroBiopsy Needle

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Daum NeuroCut NeuroBiopsy Needle). This type of document does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement in a study.

    The letter primarily confirms that the device is substantially equivalent to a previously marketed device and can therefore be legally marketed. It details regulatory classifications, general controls, and responsibilities of the manufacturer.

    Therefore, according to the provided input, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets those criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1