K253627
- 510(k) number
- K253627
- Device name
- Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
- Applicant
- Surgify Medical OY FI
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2026-03-26
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253627.pdf
Official FDA record: K253627
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.