Cleared Special

K181706 - neuromate Gen III

K181706 is an FDA 510(k) clearance for neuromate Gen III, manufactured by Renishaw Mayfield Sarl. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 28-day FDA review.

K181706 · Renishaw Mayfield Sarl · Neurology device
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Jul 2018
Decision
28d
Days
Class 2
Risk

K181706 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 July 26, 2018 after a review of 28 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.

FDA 510(k) Submission Details - K181706

510(k) Number K181706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date July 26, 2018
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 149d · This submission: 28d
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 Peers - HAW Neurological Stereotaxic Instrument

All 406
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K181706.
ROSA ONE Brain Application
K182417 · Medtech S.A · Feb 2019
AQrate Robotic Assistance System
K182000 · Globus Medical, Inc. · Jan 2019
7D Surgical System Cranial Application
K181041 · 7D Surgical, Inc. · Aug 2018
Voyager Trajectory Array Guide (V-TAG)
K180854 · Voyager Therapeutics, Inc. · Jul 2018
neuromate Gen III
K180206 · Renishaw Mayfield Sarl · Apr 2018
ROSA BRAIN (v3.0.0.5)
K172444 · Medtech S.A · Mar 2018
K181706 · neuromate Gen III
Download PDF Renishaw Mayfield Sarl