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510(k) Data Aggregation

    K Number
    K033161
    Device Name
    VISU-LOCK 5MM CLIP APPLIER
    Manufacturer
    GYRX, LLC
    Date Cleared
    2003-12-18

    (79 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VISU-LOCK 5MM CLIP APPLIER

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

    The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes an FDA 510(k) clearance letter for the Visu-Loc™ 5mm Clip Applier. It acknowledges the device's substantial equivalence to legally marketed predicate devices and details the regulatory classification and general controls. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a detailed study report.

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