Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-26 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253379.

When did Stealth AXiS Cranial clinical application receive FDA 510(k) clearance?

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

Who is the listed applicant for Stealth AXiS Cranial clinical application?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medtronic Navigation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsK250307Visualase V2 MRI-guided Laser Ablation System (9736422)

View all 33 devices →

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.K250505EZ-FIDUCIALSPhasor Health, LLC

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.

↑