Cleared Traditional

Surgify Halo

K232684 · Surgify Medical OY · Neurology
Nov 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K232684 is an FDA 510(k) clearance for the Surgify Halo, 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 November 29, 2023, 89 days after receiving the submission on September 1, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K232684 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2023
Decision Date November 29, 2023
Days to Decision 89 days
Submission Type Traditional
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

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