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510(k) Data Aggregation

    K Number
    K020987
    Device Name
    BMN I TYPE MARROW ASPIRATION NEEDLE
    Manufacturer
    H.S. HOSPITAL SERVICE S.R.L.
    Date Cleared
    2002-06-25

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K121181
    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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets the acceptance criteria. The document is a 510(k) summary for a "BMN 'I' Type Marrow Biopsy Needle," which is a premarket notification to the FDA. It includes:

    • Applicant and contact information.
    • Device name, common name, and classification.
    • Indication for use.
    • FDA's determination of substantial equivalence to a predicate device.
    • Regulatory information regarding marketing, general controls, and compliance.

    There is no mention of performance metrics, acceptance criteria, study design, results, or ground truth establishment. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study.

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