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510(k) Data Aggregation

    K Number
    K974794
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-01-23

    (32 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 :

    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE

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

    The intended use of the Worldwide Medical Technologies Bone Marrow Biopsy Needle is to obtain a sample of bone marrow for histological examination in the diagnosis and treatment of various diseases. The sample is typically taken by percutaneous puncture of the posterior iliac creast of the pelvis.

    Device Description

    Worldwide Medical Technologies Bone Marrow Biopsy Needle

    AI/ML Overview

    The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. This is a 510(k) clearance letter for a medical device (Bone Marrow Biopsy Needle), which primarily focuses on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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