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510(k) K253772

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

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

Other clearances by Adeor Medical AG

  • K191479 — Velocity Alpha Highspeed Surgical Drill System (April 11, 2021)
  • K191847 — Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-st (May 22, 2020)
  • K130755 — HICUT HIGHSPEED INSTRUMENT (June 27, 2014)

Other clearances for product code HBB

  • K172907 — ELAN 4 Air Motor System (November 9, 2018)
  • K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo (March 23, 2017)
  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM (April 14, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041754 — STRYKER MAESTRO SYSTEM (September 7, 2004)