LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974576
    Device Name
    DAUM BIOPSYGUN
    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 BIOPSYGUN

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

    The Daum BiopsyGun is deigned to automatically perform a biopsy of soft tissues. The Daum BiopsyGun is also a low-artifact-instrument designed to be used in the MRI for the above purpose.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, study details, or performance data for the "Daum BiopsyGun." The document is an FDA 510(k) clearance letter, which confirms the device's substantial equivalence to a legally marketed predicate device but does not include the specifics of performance studies. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1