Cleared Traditional

K171669 - g.Nautilus PRO

K171669 is the FDA 510(k) clearance for g.Nautilus PRO by G.Tec Medical Engineering GmbH. It is a Class 2 Neurology device (product code GWL) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K171669 · G.Tec Medical Engineering GmbH · Neurology device
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Jul 2017
Decision
30d
Days
Class 2
Risk

K171669 is an FDA 510(k) clearance for the g.Nautilus PRO. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on July 5, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G.Tec Medical Engineering GmbH devices

Submission Details

510(k) Number K171669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date July 05, 2017
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 17
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K171669.
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K841612 · Nihon Kohden America, Inc. · Jun 1984