Cleared Special

ClearPoint System and Accessories

K200079 · Mri Interventions, Inc. · Neurology
Feb 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200079 is an FDA 510(k) clearance for the ClearPoint System and Accessories, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on February 13, 2020, 30 days after receiving the submission on January 14, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K200079 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2020
Decision Date February 13, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

Similar Devices — HAW Neurological Stereotaxic Instrument

All 420
NeuroAlign software
K231897 · Medivis, Inc. · Oct 2025
SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · Brain Navi Biotechnology Co., Ltd. · May 2025
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · Claronav · Feb 2025