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510(k) Data Aggregation

    K Number
    K982735
    Device Name
    LIGHT SABER BONE BIOPSY NEEDLE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    1998-09-09

    (35 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 :

    LIGHT SABER BONE BIOPSY NEEDLE

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

    "Disposable needle for obtaining biopsies from Bone and Bone Marrow."

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is an FDA letter regarding the 510(k) clearance for a bone biopsy needle and includes sections on "Indications for Use." However, it does not detail any acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission summary. Therefore, I cannot generate the requested table or answer the specific questions about the study.

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