Stealth AXiS ENT clinical application— 510(k) K253395
Substantially EquivalentMedtronic 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.
Summary
Medtronic Navigation's Stealth AXiS ENT clinical application is filed under PGW, ear, nose, and throat stereotaxic instruments. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 882.4560. The Ear, Nose, and Throat review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Medtronic Navigation filed from Lafayette, Colorado. Review took 167 calendar days (September 30, 2025 to March 16, 2026).
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- Product code
- Product code PGW
- 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
Recent devices under product code PGW
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view allAdverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
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.