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510(k) Data Aggregation

    K Number
    K253395

    Validate with FDA (Live)

    Date Cleared
    2026-03-16

    (167 days)

    Product Code
    Regulation Number
    882.4560
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stealth AXiS™ Surgical System, with the Stealth AXiS™ ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.

    This can include, but is not limited to, the following procedures:

    • Functional endoscopic sinus surgery (FESS)
    • Endoscopic skull base procedures
    • Lateral skull base procedures
    Device Description

    The Stealth AXiS ENT Clinical Application works in conjunction with the Stealth AXiS Surgical System, which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. The Stealth AXiS™ ENT Clinical Application helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The system tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.

    AI/ML Overview

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