Cleared Traditional

K191479 - Velocity Alpha Highspeed Surgical Drill System (FDA 510(k) Clearance)

K191479 · Adeor Medical AG · Neurology device

Apr 2021

Decision

677d

Days

Class 2

Risk

K191479 is an FDA 510(k) clearance for the Velocity Alpha Highspeed Surgical Drill System. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Adeor Medical AG (Unterhaching, DE). The FDA issued a Cleared decision on April 11, 2021, 677 days after receiving the submission on June 4, 2019.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K191479 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 2019
Decision Date	April 11, 2021
Days to Decision	677 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF