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FDA 510(k)

Stealth AXiS™ ENT clinical application

K-Number: K253395 · 2026-03-16

ApplicantMedtronic Navigation, Inc.
Decision Date2026-03-16
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealth AXiS™ ENT clinical application is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-16 under approval number K253395. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stealth AXiS™ ENT clinical application?

Stealth AXiS™ ENT clinical application is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K253395.

When was Stealth AXiS™ ENT clinical application approved by the FDA?

Stealth AXiS™ ENT clinical application received FDA 510(k) clearance on 2026-03-16, under approval number K253395.

What company makes Stealth AXiS™ ENT clinical application?

Stealth AXiS™ ENT clinical application is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Stealth AXiS™ ENT clinical application?

The FDA product code for Stealth AXiS™ ENT clinical application is PGW.

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Related PubMed Literature

PMID: 42037445 Artificial Intelligence in Rhinology: A State-of-the-Art Review of Clinical Readiness and Implementation Pathways. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (2026) PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 41395509 The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses. Small science (2025)

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K153247Fusion Compact Navigation System K170018StealthStationTM S8 ENT Software K162655StealthConnect Remote Viewing, Planning and Collaboration System

View all 24 devices →

Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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