Cleared Traditional

Hubly Drill (H100)

K250815 · Hubly, Inc. · Neurology
Nov 2025
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K250815 is an FDA 510(k) clearance for the Hubly Drill (H100), a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Hubly, Inc. (Lisle, US). The FDA issued a Cleared decision on November 6, 2025, 234 days after receiving the submission on March 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K250815 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2025
Decision Date November 06, 2025
Days to Decision 234 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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