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510(k) Data Aggregation

    K Number
    K252412
    Date Cleared
    2025-10-31

    (91 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Advanced Bipolar: The Voyant electrosurgical generator is indicated for use with advanced bipolar Voyant devices in open and minimally invasive procedures where the ligation of vessels up to and including 7mm in diameter and tissue bundles is desired.

    NOTE: For indications specific to each Voyant device used with the Voyant generator, refer to each device's Instructions for Use (IFU).

    Monopolar/Bipolar: Intended to provide energy to standard monopolar and bipolar surgical accessories.

    Device Description

    The Applied Medical Voyant Electrosurgical Generator (EA030) is a reusable, electrically isolated, microprocessor-controlled power supply intended to deliver radiofrequency (RF) energy for electrosurgical applications. The system provides energy output to compatible monopolar, bipolar, and Voyant advanced bipolar instruments for the cutting, coagulation, and sealing of vessels and tissue bundles. The Voyant EA030 operates outside the sterile field and interfaces with active surgical instruments that operate within the sterile field. The system comprises integrated mechanical, electrical, and software components, constructed from various metals and polymers. It features a front-panel LCD touchscreen that enables users to view, navigate and adjust operating modes and system settings.

    Voyant EA030 is designed to function as part of a system that includes optional accessories such as active devices, footswitches, and patient return electrodes. These components work together to ensure safe and effective energy delivery during surgical procedures.

    AI/ML Overview

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