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FDA 510(k)

Stealth AXiS Cranial clinical application

K-Number: K253379 · 2026-03-26

ApplicantMedtronic Navigation, Inc.
Decision Date2026-03-26
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealth AXiS Cranial clinical application is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-26 under approval number K253379. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stealth AXiS Cranial clinical application?

Stealth AXiS Cranial clinical application is a medical device that received FDA 510(k) clearance on 2026-03-26. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K253379.

When was Stealth AXiS Cranial clinical application approved by the FDA?

Stealth AXiS Cranial clinical application received FDA 510(k) clearance on 2026-03-26, under approval number K253379.

What company makes Stealth AXiS Cranial clinical application?

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

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

The FDA product code for Stealth AXiS Cranial clinical application is HAW.

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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

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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