Home / 510(k) Clearances / K200079

510(k) K200079

ClearPoint System and Accessories by Mri Interventions, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2020
Date Received
January 14, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Mri Interventions, Inc.

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

Other clearances for product code HAW

  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (January 17, 2025)
  • K242480 — FLASH EVD System (10-0002) (December 27, 2024)