Cleared Special

K082250 - AURAGEN CORTICAL SURFACE ELECTRODES

K082250 is an FDA 510(k) clearance for AURAGEN CORTICAL SURFACE ELECTRODES, manufactured by Integra Neurosciences. The device is a Class 2 Neurology device with product code GYC cleared through the Special 510(k) pathway after a 63-day FDA review.

K082250 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
63d
Days
Class 2
Risk

K082250 is an FDA 510(k) clearance for the AURAGEN CORTICAL SURFACE ELECTRODES. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Integra Neurosciences (Planisboro, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 - K082250

510(k) Number K082250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date October 10, 2008
Days to Decision 63 days
Submission Type Special
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
86d faster than avg
Panel avg: 149d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

GYC Device Classification - Class 2, Special Controls

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 30
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K082250.
S12X WITH ESAX OPTION
K082629 · Chatten Associates, Inc. · Jul 2009
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · Pmt Corp. · May 2009
NICOLET CORTICAL STIMULATOR
K072964 · Cardinal Health, Inc. · Dec 2008
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp · May 2006
SUBDURAL STRIP ELECTRODE
K021144 · Nicolet Biomedical, Inc. · Jun 2002
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · Ad-Tech Medical Instrument Corp · Sep 1999
K082250 · AURAGEN CORTICAL SURFACE ELECTRODES
Download PDF FDA Summary Integra Neurosciences