Cleared Special

K250380 - Surgify Halo (54.085.SHD.H1) (FDA 510(k) Clearance)

Also includes:
Surgify Halo (54.140.SHD.H1) Surgify Halo (54.070.NVG.H1) Surgify Halo (54.125.NVG.H1) Surgify Halo (54.000.SEE.H1)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250380 · Surgify Medical OY · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
30d
Days
Class 2
Risk

K250380 is an FDA 510(k) clearance for the Surgify Halo (54.085.SHD.H1). Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Surgify Medical OY (Espoo, FI). The FDA issued a Cleared decision on March 13, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surgify Medical OY devices

Submission Details

510(k) Number K250380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Avania, LLC
Richard Lilly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K250380.
Surgify Halo (54.085.SHD.U1)
K253627 · Surgify Medical OY · Mar 2026
Hubly Drill (H100)
K250815 · Hubly, Inc. · Nov 2025
GREEN
K252060 · Phasor Health, LLC · Oct 2025
UniBur
K252662 · Nakanishi, Inc. · Sep 2025
Surgify Halo (54.085.SHD.H1)
K251433 · Surgify Medical OY · Jun 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · Stryker Instruments · Mar 2025