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510(k) Data Aggregation

    K Number
    K254220

    Validate with FDA (Live)

    Device Name
    Reusable 3 Button Fingerswitch Wand
    Manufacturer
    Soniquence, LLC
    Date Cleared
    2026-01-27

    (29 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K183611,K212222
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures

    Device Description

    The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes.

    The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode.

    a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates.
    b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
    c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

    AI/ML Overview

    N/A

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