K231976
- 510(k) number
- K231976
- Device name
- StealthStation Cranial Software, v3.1.5 (9735585)
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2023-10-19
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231976.pdf
Official FDA record: K231976
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.