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Stealth AXiS ENT clinical application

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253395

by Medtronic Navigation, Inc.

Identifiers

510(k) Number
K253395 FDA 510(k)
FDA Product Code
PGW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stealth AXiS ENT clinical application is a software component of the Stealth AXiS Surgical System that provides intraoperative surgical navigation. It uses electromagnetic localization to track surgical instruments relative to patient anatomy, with inputs including preoperative or intraoperative images such as X-ray, MR, and nuclear medicine.

This device is supplied as part of the Stealth AXiS Surgical System and is intended for use in ENT procedures. It is a Class II device with FDA 510(k) clearance (K253395) and is manufactured by Medtronic Navigation, Inc. The system is designed to bring surgical planning, navigation, and software intelligence together in a single, scalable platform for ENT workflows.

Frequently asked questions

What is the Stealth AXiS ENT clinical application used for?

The Stealth AXiS ENT clinical application is a software component that provides intraoperative surgical navigation for ENT procedures. It uses electromagnetic localization to track surgical instruments relative to patient anatomy, utilizing inputs like X-ray, MR, and nuclear medicine images.

How is the Stealth AXiS ENT clinical application supplied?

This device is supplied as part of the Stealth AXiS Surgical System, which brings surgical planning, navigation, and software intelligence together in a single, scalable platform specifically designed for ENT workflows.

What is the regulatory status of the Stealth AXiS ENT clinical application?

The Stealth AXiS ENT clinical application is a Class II device with FDA 510(k) clearance (K253395), meaning it has been determined to be substantially equivalent to existing devices in the Ear, Nose, And Throat Stereotaxic Instrument category.

What types of images can be used with the Stealth AXiS ENT clinical application?

The application can utilize various types of medical images for navigation, including preoperative or intraoperative images such as X-ray, MR (magnetic resonance), and nuclear medicine images to provide comprehensive anatomical reference during procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stealth AXiS™ ENT navigation system - Medtronic, Stealth AXiS™ ENT clinical application (K253395) - Innolitics, K253395 FDA 510 (k) - Stealth AXiS ENT clinical application

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Navigation, Inc.

Sources (1)

  • FDA 510(k) K253395 24 fields · synced Sep 26, 2026