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    K Number
    K022593
    Device Name
    THOMAS MEDICAL ELECTRODES
    Manufacturer
    THOMAS MEDICAL, INC.
    Date Cleared
    2002-11-01

    (88 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THOMAS MEDICAL ELECTRODES

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

    To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Thomas Medical Electrodes. It is a regulatory document and does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) because these types of studies are not typically required for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the given text. The prompt asks for details about a study that proves the device meets acceptance criteria, but this document only states that the device is substantially equivalent to a predicate device and can proceed to market.

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