Clearance Summary
Stealth AXiS Cranial clinical application received FDA 510(k) clearance under submission number K253379, sponsored by Medtronic Navigation, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-03-26.
- Submission: K253379
- Applicant / Sponsor: Medtronic Navigation, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2026-03-26
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.