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510(k) Data Aggregation

    K Number
    K981477
    Device Name
    MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
    Date Cleared
    1998-06-10

    (47 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL BIOPSY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Biopsy Automatic Cutting Needle is intended for use in obtaining samples of tissues or lesions. Medical Biopsy's Automatic Biopsy Needle is intended for use in obtaining samples of tissues or lesions from the Breast, Kidney, Prostate and Liver.
    Device Description
    The Medical Biopsy Automatic Cutting Needle is a two-piece design consisting of a cannula and an obturator (stylet). The needles are made of 304 Stainless Steel. Etched markings have been incorporated along the shaft of both the cannula and the obturator, at intervals of 1cm, to guide depth of insertion. The distal end of the stylet is notched for tissue retention. The proximal end of the Automatic Cutting Needle incorporates a plastic fitting for attachment to the "gun" portion of the Biopsy System, which houses, guides and manipulates the Automatic Cutting Needle during use. This "gun" component is sold separately by another company and is not covered within this 510(k) Premarket Notification.
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