510(k) K253772

Velocity Alpha MR High Speed Surgical Drill System by Adeor Medical AG — Product Code HBB

K253772 is an FDA 510(k) premarket notification submitted by Adeor Medical AG for the device "Velocity Alpha MR High Speed Surgical Drill System". The FDA issued a decision of Substantially Equivalent on March 6, 2026. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Adeor Medical AG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2026
Date Received
November 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type