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510(k) Data Aggregation

    K Number
    K973215
    Device Name
    STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
    Manufacturer
    LAURUS MEDICAL CORP.
    Date Cleared
    1997-11-06

    (71 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 Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but without text from the document describing the acceptance criteria or a study related to device performance, I cannot provide the requested information. The provided text only contains a letter from the FDA regarding a 510(k) submission for a Stereotactic Needle Core Biopsy Device, indicating its clearance for marketing and its intended use. It does not include any details about acceptance criteria, study design, or performance metrics.

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