Surgify Halo (11 models)— 510(k) K253627

Name: FDA 510(k) clearance K253627
Creator: U.S. Food and Drug Administration
Published: 2026-03-26

Substantially Equivalent

Surgify 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.

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: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2025-11-19
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBE

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K250815 — Hubly Drill (H100)2025-11-06
K252060 — GREEN2025-10-31
K252662 — UniBur2025-09-19
K251433 — Surgify Halo (8 models)2025-06-04
K250380 — Surgify Halo (5 models)2025-03-13

More clearances from Surgify Medical OY

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K232684 — Surgify Halo2023-11-29

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2556-2026 — Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2557-2026 — Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2559-2026 — Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2561-2026 — Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2563-2026 — Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2565-2026 — Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2567-2026 — Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2569-2026 — Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2571-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2573-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430

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.