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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253395.

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

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

Who is the listed applicant for Stealth AXiS™ ENT 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™ ENT clinical application?

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

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.

K253379Stealth AXiS Cranial 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)

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Related Devices (Code: PGW)

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.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, Inc.K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation

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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