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510(k) K132436

VARIOGUIDE DRILL KIT by Mri Interventions, Inc. — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2014
Date Received
August 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
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)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)

Other clearances for product code HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K252662 — UniBur (September 19, 2025)
  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)