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510(k) K122456

MRII CRAINIAL DRILL by Mri Interventions, Inc. — Product Code HBG

K122456 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "MRII CRAINIAL DRILL". The FDA issued a decision of Substantially Equivalent on March 22, 2013. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2013
Date Received
August 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Mri Interventions, Inc.

  • K200079 — ClearPoint System and Accessories (February 13, 2020)
  • K191701 — Arcus Head Fixation Frame (November 15, 2019)
  • K191400 — Voyager Trajectory Array Guide (V-TAG) (June 21, 2019)
  • K181731 — MR Compatible Aspiration Kit (November 20, 2018)
  • K181195 — ClearPoint System (November 2, 2018)
  • K171257 — ClearPoint System (October 20, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K160434 — ClearPoint System (March 17, 2016)
  • K142505 — ClearPoint System (October 21, 2015)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)

Other clearances for product code HBG

  • K252696 — LEGACY (November 21, 2025)
  • K153587 — Taps for Resorbable Screws (January 18, 2017)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)

FDA data resources