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510(k) Data Aggregation

    K Number
    K190643
    Device Name
    Medline Electrocautery Pencil
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2019-05-06

    (54 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Medline Electrocautery Pencil

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

    The Medline Electrocautery Pencil is intended to be used in electrosurgical procedures to remove tissue and control bleeding by use of high frequency electrical current. The device can be used for both cutting and coagulating.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Medline Electrocautery Pencil. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    Therefore, I cannot provide the requested information from this document.

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