Stealth AXiS ENT clinical application— 510(k) K253395

Name: FDA 510(k) clearance K253395
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K253395 for Stealth AXiS ENT clinical application, Substantially Equivalent on 2026-03-16. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code PGW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-09-30
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PGW

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K261540 — Cube 4D Navigation System, VirtuEye Pro2026-06-02
K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC)2025-06-20
K231862 — TruDi® Navigation System V3 (FG-2000-00)2023-07-21
K223734 — ENT EM2023-04-27
K221037 — TruDi Shaver Blade2022-07-20

More clearances from Medtronic Navigation, Inc.

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K253379 — Stealth AXiS Cranial clinical application2026-03-26
K253391 — Visualase Cooled Laser Applicator System (3 models)2026-03-13
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application2026-02-12
K251282 — StealthStation S8 Spine Software2025-10-17
K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts2025-06-05

Adverse events under product code PGW

product code PGW

Malfunction: 1,199
Total: 1,199

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.