K253379
- 510(k) number
- K253379
- Device name
- Stealth AXiS Cranial clinical application
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2026-03-26
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253379.pdf
Official FDA record: K253379
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.