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510(k) Data Aggregation

    K Number
    K253680

    Validate with FDA (Live)

    Device Name
    LYNX COBLATION Laryngeal Wand (72290254)
    Manufacturer
    ArthroCare Corporation
    Date Cleared
    2026-03-25

    (124 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K192027,K202006
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LYNX◊ COBLATION◊ Laryngeal Wand is indicated for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels for otorhinolaryngology (ENT) procedures of the larynx and trachea.

    The LYNX™ COBLATION™ Laryngeal Wand is intended for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology (ENT) procedures.

    It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. It is intended to be used with qualified controllers.

    Device Description

    The LYNX COBLATION Laryngeal Wand is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) procedures. The device is intended to work with Qualified Controllers (WEREWOLF COBLATION SYSTEM (WEREWOLF ENT and WEREWOLF +). There are no changes to the WEREWOLF Controllers or Irrigation pump for use with LYNX Wand.

    The LYNX Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended:

    • An integrated suction line allows connection to suction source within the operating environment.
    • An integrated saline tube set designed to be compatible with the WEREWOLF flow control module allows connection with saline source within the operating environment.
    • An integrated cable compatible with the WEREWOLF controller.

    The device operates in Coblation (resection/ablation) and Coagulation (coagulation/hemostasis) modes by using their biopolar configuration to create energy field using a conductive irrigating solution.

    AI/ML Overview

    N/A

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