K232684
- 510(k) number
- K232684
- Device name
- Surgify Halo
- Applicant
- Surgify Medical OY FI
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2023-11-29
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K232684.pdf
Official FDA record: K232684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.