DeviceClearance

Stealth AXiS Cranial clinical application— 510(k) K253379

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K253379 for Stealth AXiS Cranial clinical application, Substantially Equivalent on 2026-03-26. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Summary

Medtronic Navigation's Stealth AXiS Cranial clinical application is filed under HAW, neurological stereotaxic instruments. The record doesn't describe it beyond its name and that code name.

Class II, 21 CFR 882.4560. Neurology is both the classification panel and the review panel. It was a Traditional 510(k).

Medtronic Navigation filed from Lafayette, Colorado. The decision came 177 calendar days after receipt (September 30, 2025 to March 26, 2026).

Clearance details

Applicant
Medtronic Navigation, Inc.
Product code
Product code HAW
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lafayette, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HAW

product code HAW
Death
52
Injury
1,083
Malfunction
17,300
Total
18,435

Source: openFDA MAUDE database, through . 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.