Cleared Traditional

Velocity Alpha Highspeed Surgical Drill System

K191479 · Adeor Medical AG · Neurology
Apr 2021
Decision
677d
Days
Class 2
Risk

About This 510(k) Submission

K191479 is an FDA 510(k) clearance for the Velocity Alpha Highspeed Surgical Drill System, 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 review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K191479 FDA.gov
FDA Decision Cleared 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

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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