K253395
- 510(k) number
- K253395
- Device name
- Stealth AXiS ENT clinical application
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- PGW — Ear, Nose, And Throat Stereotaxic Instrument
- Decision date
- 2026-03-16
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253395.pdf
Official FDA record: K253395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.