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510(k) Data Aggregation

    K Number
    K971061
    Device Name
    OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
    Manufacturer
    OPPORTUNITY, INC.
    Date Cleared
    1997-06-11

    (79 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

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

    Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.

    Device Description

    Bone Marrow Biopsy and Aspiration Tray

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a "Bone Marrow Biopsy and Aspiration Tray," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, such as good manufacturing practices, labeling, and drug components within the kit, but it does not detail performance metrics or studies performed to prove the device meets specific acceptance criteria.

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