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510(k) Data Aggregation

    K Number
    K992485
    Device Name
    MONOPOLAR ELECTRODES AND CABLES
    Manufacturer
    US ENDO, INC.
    Date Cleared
    1999-08-27

    (32 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate tissue, for use with HF Electrosurgical Units

    Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region.

    The device is reusable, non-sterile, for use as follows:

    1. Spatula tip-Dissection-Coagulation & manipulation of tissue.
    2. L-Hook tip-Dissection & manipulation
    3. J-Hook tip-Core out with a knife-cutting effect (ablation)
    4. Knife-tip-Coagulate with scalpel-like cutting
    5. Button/Needle-tip-Spot coagulation
    Device Description

    Monopolar Electrodes and Accessories

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Monopolar Electrodes and Cables" and the associated "Indications for Use Statement". It does not contain information about acceptance criteria, device performance, or any studies as requested. The device mentioned is a traditional medical instrument, not an AI/ML powered device, so many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, training set size) are not applicable.

    Therefore, I cannot provide the requested information based on the given input.

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