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510(k) Data Aggregation

    K Number
    K173889
    Device Name
    Medline Cautery Electrode (PTFE)
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2018-04-09

    (109 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 Medline PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a Medline Cautery Electrode (PTFE). It is a letter from the FDA determining substantial equivalence for a medical device. This document does not contain information regarding the acceptance criteria, study details, or performance of a device that uses AI. The product described is an electrosurgical cutting and coagulation device accessory, which is a physical device, not an AI or software-based system.

    Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance based on this input.

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