K253379

Substantially Equivalent

Stealth AXiS Cranial clinical application

Applicant: Medtronic Navigation, Inc.
Product code: HAW
Advisory panel: Neurology
Date received: 2025-09-30
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.