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510(k) Data Aggregation

    K Number
    K972335
    Device Name
    CLEANCUT
    Manufacturer
    MEDQUEST PRODUCTS, INC.
    Date Cleared
    1999-01-07

    (563 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

    MedQuest Products Inc.'s Clean-Cut™ electrodes are intended for use in electrosurgery to perform cutting, coagulation, dessication, and fulguration. Each electrode is intended to be a disposable electrode, designed to fit standard electrosurgical pencils, and to be powered by standard electrosurgical generators.

    Device Description

    CleanCut Electrosurgery Electrode

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding the "CleanCut Electrosurgery Electrode." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about:

    • Acceptance criteria or reported device performance.
    • The study that proves the device meets acceptance criteria.
    • Sample sizes for test or training sets, nor data provenance.
    • Number/qualifications of experts used for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone (algorithm only) performance studies.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    This document is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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