Home / 510(k) Clearances / K160434

510(k) K160434

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2016
Date Received
February 16, 2016
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.

  • 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)
  • 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)