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510(k) Data Aggregation

    K Number
    K012725
    Device Name
    TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2001-11-08

    (85 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K012525
    Why did this record match?
    Device Name :

    TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES

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

    The Endo-Therapeutics Laparoscopic Surgical Instruments are a line of reusable general surgical forceps, graspers and scissors intended to be used for lifting, dissecting, cutting organs and tissue during general open and laparoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them. The document is an FDA 510(k) clearance letter for "Endo-Therapeutics Laparoscopic Instruments," indicating that the device has been found substantially equivalent to a predicate device. It specifies the product's intended use but does not detail any performance studies, acceptance criteria, or ground truth establishment. Therefore, I cannot extract the requested information.

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