K250380 is an FDA 510(k) clearance for the Surgify Halo (54.085.SHD.H1). This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Surgify Medical OY (Espoo, FI). The FDA issued a Cleared decision on March 13, 2025, 30 days after receiving the submission on February 11, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K250380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2025 |
| Decision Date | March 13, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE - Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |