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FDA 510(k)

Velocity Alpha Highspeed Surgical Drill System

K-Number: K191479 · 2021-04-11

ApplicantAdeor Medical AG
Decision Date2021-04-11
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Velocity Alpha Highspeed Surgical Drill System is a medical device manufactured by Adeor Medical AG. It received FDA 510(k) clearance on 2021-04-11 under approval number K191479. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velocity Alpha Highspeed Surgical Drill System?

Velocity Alpha Highspeed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2021-04-11. It is manufactured by Adeor Medical AG. The 510(k) number is K191479.

When was Velocity Alpha Highspeed Surgical Drill System approved by the FDA?

Velocity Alpha Highspeed Surgical Drill System received FDA 510(k) clearance on 2021-04-11, under approval number K191479.

What company makes Velocity Alpha Highspeed Surgical Drill System?

Velocity Alpha Highspeed Surgical Drill System is manufactured by Adeor Medical AG.

What is the FDA product code for Velocity Alpha Highspeed Surgical Drill System?

The FDA product code for Velocity Alpha Highspeed Surgical Drill System is HBE.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Adeor Medical AG

K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps K253772Velocity Alpha MR High Speed Surgical Drill System

Related Devices (Code: HBE)

K161704Phasor DrillBiotex, Inc. K153519DRealCarevature Medical, Ltd. K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation K162542OsteoMed PINNACLE DriverOsteomed K172709ELAN 4 Electro Motor System ToolsAesculap, Inc. K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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