Cleared Traditional

K230619 - Hubly Electric Drill (H100) (FDA 510(k) Clearance)

K230619 · Hubly, Inc. · Neurology device

May 2023

Decision

59d

Days

Class 2

Risk

K230619 is an FDA 510(k) clearance for the Hubly Electric Drill (H100). This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K230619 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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