Cleared Traditional

neuromate Gen III (K180206) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180206 · Renishaw Mayfield Sarl · Neurology device
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Apr 2018
Decision
90d
Days
Class 2
Risk

K180206 is an FDA 510(k) clearance for the neuromate Gen III. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Renishaw Mayfield Sarl (Chassieu, FR). The FDA issued a Cleared decision on April 24, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Renishaw Mayfield Sarl devices

Submission Details

510(k) Number K180206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date April 24, 2018
Days to Decision 90 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HAW Neurological Stereotaxic Instrument

All 163
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K180206.
7D Surgical System Cranial Application
K181041 · 7D Surgical, Inc. · Aug 2018
neuromate Gen III
K181706 · Renishaw Mayfield Sarl · Jul 2018
Voyager Trajectory Array Guide (V-TAG)
K180854 · Voyager Therapeutics, Inc. · Jul 2018
ROSA BRAIN (v3.0.0.5)
K172444 · Medtech S.A · Mar 2018
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
K162929 · Stryker Corporation · Feb 2017