Cleared Traditional

Hubly Electric Drill (H100)

K230619 · Hubly, Inc. · Neurology
May 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K230619 is an FDA 510(k) clearance for the Hubly Electric 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 May 4, 2023, 59 days after receiving the submission on March 6, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K230619 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2023
Decision Date May 04, 2023
Days to Decision 59 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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