Surgify Halo (5 models)— 510(k) K250380

Name: FDA 510(k) clearance K250380
Creator: U.S. Food and Drug Administration
Published: 2025-03-13

Substantially Equivalent

Surgify Medical OY

FDA 510(k) clearance K250380 for Surgify Halo (5 models), Substantially Equivalent on 2025-03-13. Applicant: Surgify Medical OY. Device class: 2.

Clearance details

Device name as filed: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
Applicant: Surgify Medical OY
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2025-02-11
Decision date: 2025-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Espoo, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBE

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K253627 — Surgify Halo (11 models)2026-03-26
K250815 — Hubly Drill (H100)2025-11-06
K252060 — GREEN2025-10-31
K252662 — UniBur2025-09-19
K251433 — Surgify Halo (8 models)2025-06-04

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 K250380

K-number listed on FDA's recall record

Z-2564-2026 — Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2566-2026 — Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2568-2026 — Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2570-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)Class II·Ongoing·SURGIFY MEDICAL OY·20260430
Z-2572-2026 — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; 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 K250380.

Data sourced from openFDA. This site is unofficial and independent of the FDA.