510(k) Report

FDA applicant

Surgify Medical OY

Espoo, FI4 decisions2023–202619 recalls

FDA records 4 decisions for Surgify Medical OY (Espoo, FI) from 2023 to 2026: 4 510(k) clearances. All are in product code HBE (Drills, Burrs, Trephines & Accessories…). Its devices cite 4 predicates, 3 of them its own earlier devices. 19 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Surgify Medical OY’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2023: 12025: 22026 (partial year): 1
2023high 2 (2025) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

19in 2026

2026 (partial year): 19
2023high 19 (2026) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Surgify Medical OY by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20251cites it
  • K232684Surgify HaloSurgify Medical OY · 20231cites it
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20251cites it

What has FDA decided for it lately?

  • K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo…Surgify Medical OY · 202611 recalls
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20253 recalls
  • K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20255 recalls
  • K232684Surgify HaloSurgify Medical OY · 2023

All 4 as Surgify Medical OY →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K250380Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs…Apr 30, 2026Class II
  • K253627Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs…Apr 30, 2026Class II
  • K253627Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs…Apr 30, 2026Class II
  • K251433Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs…Apr 30, 2026Class II
  • K253627Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs…Apr 30, 2026Class II
  • K250380Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs…Apr 30, 2026Class II