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510(k) Data Aggregation

    K Number
    K024266
    Device Name
    MSI TA ELECTRODES
    Manufacturer
    MEDSPHERE INTERNATIONAL, INC
    Date Cleared
    2003-03-12

    (79 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

    Indicated for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "MSI TA Electrodes" for electrosurgical cutting and coagulation. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include performance metrics, sample sizes, expert qualifications, or details about ground truth establishment.

    Therefore, I cannot answer your request based on the provided input. This document is a regulatory approval letter, not a scientific study report.

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