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510(k) Data Aggregation

    K Number
    K970489
    Device Name
    COMEG ENDOSCOPY GRASPING FORCEPS
    Manufacturer
    COMEG ENDOSCOPY
    Date Cleared
    1997-03-19

    (37 days)

    Product Code
    FFL
    Regulation Number
    876.4680
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COMEG ENDOSCOPY GRASPING FORCEPS

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

    The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.

    Device Description

    The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.

    AI/ML Overview

    The provided text is a summary of safety and effectiveness for grasping forceps (K970489) and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/algorithm performance. It primarily focuses on the regulatory submission details for a medical device (grasping forceps) in 1997, comparing it to a legally marketed substantially equivalent device.

    Therefore, I cannot extract the requested information based on the provided input. The document describes a medical device and its intended use, rather than a study evaluating device performance against acceptance criteria using expert-reviewed data.

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