Cleared Traditional

UniBur

K252662 · Nakanishi, Inc. · Neurology
Sep 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K252662 is an FDA 510(k) clearance for the UniBur, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on September 19, 2025, 28 days after receiving the submission on August 22, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K252662 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2025
Decision Date September 19, 2025
Days to Decision 28 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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