Cleared Traditional

K163666 - neuro inspire

K163666 is an FDA 510(k) clearance for neuro inspire, manufactured by Rensihaw Plc. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K163666 · Rensihaw Plc · Neurology device
Download Printable Device Report (PDF)
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Sep 2017
Decision
262d
Days
Class 2
Risk

K163666 is an FDA 510(k) clearance for the neuro inspire. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Rensihaw Plc (Wotton-Under-Edge, GB). The FDA issued a Cleared decision on September 15, 2017 after a review of 262 days - an extended review cycle.

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 Rensihaw Plc devices

FDA 510(k) Submission Details - K163666

510(k) Number K163666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date September 15, 2017
Days to Decision 262 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 148d · This submission: 262d
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 267
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K163666.
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Leksell Vantage Stereotactic System
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StealthConnect Remote Viewing, Planning and Collaboration System
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StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · Medtronic Navigation, Inc. · Mar 2017