Surgify Halo (11 models)— 510(k) K253627
Substantially EquivalentSurgify Medical OY
FDA 510(k) clearance K253627 for Surgify Halo (11 models), Substantially Equivalent on 2026-03-26. Applicant: Surgify Medical OY. Device class: 2.
Summary
Surgify Medical OY's record lists 11 Surgify Halo entries, each with its own designation, from 54.085.SHD.U1 to 30.000.SEE.U2. They're filed under HBE, simple and powered drills, burrs, trephines and accessories.
Class II, 21 CFR 882.4310. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Surgify Medical filed from Espoo, Finland. Review took 127 calendar days (November 19, 2025 to March 26, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Espoo, FI
Recent devices under product code HBE
view allMore clearances from Surgify Medical OY
view allAdverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K253627
K-number listed on FDA's recall record- Z-2555-2026 — Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
- Z-2556-2026 — Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
- Z-2557-2026 — Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
- Z-2559-2026 — Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2561-2026 — Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2563-2026 — Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2565-2026 — Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2567-2026 — Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2569-2026 — Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2571-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Z-2573-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K253627.
Data sourced from openFDA. This site is unofficial and independent of the FDA.