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510(k) K151536

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm by Mri Interventions, Inc. — Product Code HBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2015
Date Received
June 8, 2015
Clearance Type
Special
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.

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  • 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)
  • K132436 — VARIOGUIDE DRILL KIT (March 20, 2014)

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)
  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • 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)