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510(k) Data Aggregation

    K Number
    K120189
    Device Name
    BONETRAP
    Manufacturer
    BERNI FARNS INCORPORATED
    Date Cleared
    2012-02-22

    (30 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.

    Device Description

    A disposable single use Biopsy Needle

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for the BONETRAP Bone Marrow Biopsy Needle. The document is a 510(k) summary and an FDA approval letter, which primarily focus on the device's substantial equivalence to a predicate device and its indications for use, not on a detailed performance study with specific metrics and methodologies.

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