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510(k) K222519

ClearPoint System by ClearPoint Neuro, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
August 19, 2022
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 ClearPoint Neuro, Inc.

  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • DEN240023 — SmartFlow Neuro Cannula (November 13, 2024)
  • K233703 — Bone Anchor (NGS-BA-01) (April 26, 2024)
  • K233155 — ClearPointer Optical Navigation Wand (January 12, 2024)
  • K233144 — ClearPoint Bone Screw Fiducials (January 12, 2024)
  • K233141 — SmartFrame OR (January 12, 2024)
  • K233243 — ClearPoint System (Software Version 2.2) (November 27, 2023)
  • K232102 — ClearPoint Array System (Version 1.2) (September 15, 2023)
  • K213645 — ClearPoint Maestro Brain Model (August 8, 2022)
  • K214040 — ClearPoint Array System (version 1.1) (April 12, 2022)

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)