Cleared Traditional

K060803 - G.USBAMP

K060803 is an FDA 510(k) clearance for G.USBAMP, manufactured by G.Tec Medical Engineering GmbH. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K060803 · G.Tec Medical Engineering GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
39d
Days
Class 2
Risk

K060803 is an FDA 510(k) clearance for the G.USBAMP. 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 May 2, 2006 after a review of 39 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

FDA 510(k) Submission Details - K060803

510(k) Number K060803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date May 02, 2006
Days to Decision 39 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
109d faster than avg
Panel avg: 148d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GWL Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K060803.
g.HIamp
K123255 · G.Tec Medical Engineering GmbH · Dec 2012
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NEUROMETRIX BIOAMPLIFIER
K083322 · Neurometrix, Inc. · May 2009
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K051852 · Allergan, Inc. · Sep 2005
NIC36 AMPLIFIER
K041198 · Eb Neuro S.P.A. · Jun 2004
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997