Cleared Special

K160434 - ClearPoint System

K160434 is an FDA 510(k) clearance for ClearPoint System, manufactured by Mri Interventions, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 30-day FDA review.

K160434 · Mri Interventions, Inc. · Neurology device
Download Printable Device Report (PDF)
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Mar 2016
Decision
30d
Days
Class 2
Risk

K160434 is an FDA 510(k) clearance for the ClearPoint System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 17, 2016 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mri Interventions, Inc. devices

FDA 510(k) Submission Details - K160434

510(k) Number K160434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date March 17, 2016
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 331
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