Cleared Special

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)

K250380 · Surgify Medical OY · Neurology

Mar 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250380 is an FDA 510(k) clearance for the 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), 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 review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K250380 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4310

Manufacturer

Surgify Medical OY

Espoo · FI

Jukka Kreander

3 submissions 3 cleared

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