K250505
- 510(k) number
- K250505
- Device name
- EZ-FIDUCIALS
- Applicant
- Phasor Health, LLC TX · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-07-09
- Date received
- 2025-02-21
- 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: K250505.pdf
Official FDA record: K250505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.