Velocity Alpha MR High Speed Surgical Drill System— 510(k) K253772
Substantially EquivalentAdeor Medical AG
FDA 510(k) clearance K253772 for Velocity Alpha MR High Speed Surgical Drill System, Substantially Equivalent on 2026-03-06. Applicant: Adeor Medical AG. Device class: 2.
Summary
Adeor Medical's Velocity Alpha MR High Speed Surgical Drill System is filed under HBB, pneumatic drill motors. The record doesn't list attachments or components.
Class II, 21 CFR 882.4370. It was a Traditional 510(k), and Neurology is both the classification panel and the review panel.
Adeor Medical filed from Valley, Germany. The decision came 100 calendar days after FDA received it (November 26, 2025 to March 6, 2026).
Clearance details
- Applicant
- Adeor Medical AG
- Product code
- Product code HBB
- Device class
- Class 2
- Regulation
- 21 CFR 882.4370
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valley, DE
Recent devices under product code HBB
view allMore clearances from Adeor Medical AG
view allAdverse events under product code HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.