Cleared Traditional

Velocity Alpha MR High Speed Surgical Drill System

K253772 · Adeor Medical AG · Neurology
Mar 2026
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K253772 is an FDA 510(k) clearance for the Velocity Alpha MR High Speed Surgical Drill System, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Adeor Medical AG (Valley, DE). The FDA issued a Cleared decision on March 6, 2026, 100 days after receiving the submission on November 26, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K253772 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2025
Decision Date March 06, 2026
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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