Cleared Traditional

K180206 - neuromate Gen III

K180206 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 Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K180206

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.

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 265
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K180206.
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K172820 · Brainlab AG · Mar 2018
Leksell Vantage Stereotactic System
K171123 · Elekta Instrument AB · Sep 2017