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510(k) Data Aggregation

    K Number
    K962271
    Device Name
    ELECTROSURGICAL ELECRTRODES
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Date Cleared
    1997-08-08

    (421 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Directed Biopsy
    2. Removal of submucous fibroids and large polyps
    3. Submucous myomectomy
    4. Transection of intrauterine adhesions
    5. Transection of intrauterine septa
    6. Endometrial ablation
    Device Description

    Northgate's Cutting Loops and Knife Electrosurgical Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.

    The Vapor-Tech Series Electrodes are designed with several tip configurations: roller ball, roller barrel, cross grooved, grooved roller, ball, and Sled™

    AI/ML Overview

    The provided text is a 510(k) premarket notification for electrosurgical electrodes. It describes the device, its intended use, and states its substantial equivalence to other marketed devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details requested in the prompt.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory submission stating substantial equivalence rather than a detailed report of device performance studies.

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