K250380
- 510(k) number
- K250380
- Device name
- Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
- Applicant
- Surgify Medical OY FI
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2025-03-13
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250380.pdf
Official FDA record: K250380
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.