Velocity Alpha MR High Speed Surgical Drill System

Q: What is the product code of K253772?

The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.

FDA 510(k) K253772 · Adeor Medical AG

Substantially Equivalent

510(k) numberK253772

Submission

Device name: Velocity Alpha MR High Speed Surgical Drill System
Applicant: Adeor Medical AG
Valley, DE
Received: November 26, 2025
Decision date: March 6, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBB – Motor, Drill, Pneumatic
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4370
Specialty: Neurology

Other 510(k)s with product code HBB

510(k)	Device	Applicant	Decision
K172907	ELAN 4 Air Motor SystemHBB · Traditional	Aesculap, Inc.	11/09/2018SE
K163182	Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…HBB · Traditional	Medtronic Powered Surgical Solutions	03/23/2017SE
K150801	Stryker Maestro Air MotorsHBB · Special	Stryker Corporation	05/22/2015SE
K101168	Legend Power Adapter Model: 6475000HBB · Traditional	Medtronic Sofamor Danek	08/24/2010SE
K093361	Synthes Air Pen Drive (Apd) SystemHBB · Traditional	Synthes (Usa)	04/14/2010SE
K090112	Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700HBB · Traditional	Medtronic Powered Surgical Solutions	03/26/2009SE
K061297	Anspach Imri Safe Surgical Drill SystemHBB · Traditional	The Anspach Effort, Inc.	01/26/2007SE
K061725	Stryker Aria Pneumatic SystemHBB · Traditional	Stryker Instruments	10/26/2006SE
K042974	Medicon Vipair High Speed SystemHBB · Traditional	Medicon EG	01/13/2005SE
K041754	Stryker Maestro SystemHBB · Traditional	Stryker Corp.	09/07/2004SE

More from Stryker Corp.

510(k)	Device	Decision
K191479	Velocity Alpha Highspeed Surgical Drill SystemHBE · Traditional	04/11/2021SE
K191847	Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick…GEI · Traditional	05/22/2020SE
K130755	Hicut Highspeed InstrumentHBE · Traditional	06/27/2014SE

Questions and answers

When was Velocity Alpha MR High Speed Surgical Drill System cleared by the FDA?

Velocity Alpha MR High Speed Surgical Drill System (K253772) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 100 days after the submission was received.

What is the product code of K253772?

The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.