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510(k) Data Aggregation

    K Number
    K974793
    Device Name
    ELMED ESU 120 M/M DIGITAL
    Manufacturer
    ELMED, INC.
    Date Cleared
    1998-03-19

    (87 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 EIMED ESU 120 M/M DIGITAL is a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bimlar coagulation.

    Device Description

    ELMED ESU 120 M/M DIGITAL is an electrosurgical system.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the 'ELMED ESU 120 M/M DIGITAL' electrosurgical system. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and study details. This document is a regulatory clearance letter, not a scientific study report.

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