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510(k) Data Aggregation

    K Number
    K980068
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-01-23

    (15 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

    The intended use of the Worldwide Medical Technologies " I " Type Bone Marrow Aspiration Needle is for the percutaneous puncture of the sternum to obtain a sample of the bone marrow for pathological examination in the diagnosis and treatment of various diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "Worldwide Medical Technologies 'I' Type Bone Marrow Aspiration Biopsy Needle." This document grants market clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    Therefore, I cannot provide the requested information from this document. The questions posed are typically relevant to the performance evaluation of AI/ML-driven medical devices, which this document does not describe.

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