Cleared Traditional

ClearPoint System

K171257 · Mri Interventions, Inc. · Neurology
Oct 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K171257 is an FDA 510(k) clearance for the ClearPoint System, a Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (Class II — Special Controls, product code ORR), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 2017, 175 days after receiving the submission on April 28, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K171257 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2017
Decision Date October 20, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code ORR — Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite.