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510(k) Data Aggregation

    K Number
    K981301
    Device Name
    SPEED-CUT AUTOMATIC BIOPSY SYSTEM
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-07-08

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPEED-CUT AUTOMATIC BIOPSY SYSTEM

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

    The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

    Device Description

    The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Speed-Cut Automatic Biopsy System and only confirms the device's substantial equivalence to a predicate device. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information.

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