510(k) K253395— Stealth AXiS ENT clinical application

Substantially Equivalent

Medtronic Navigation, Inc.

Clearance details

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

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.