Cleared Abbreviated

K021144 - SUBDURAL STRIP ELECTRODE

K021144 is an FDA 510(k) clearance for SUBDURAL STRIP ELECTRODE, manufactured by Nicolet Biomedical, Inc.. The device is a Class 2 Neurology device with product code GYC cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K021144 · Nicolet Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
76d
Days
Class 2
Risk

K021144 is an FDA 510(k) clearance for the SUBDURAL STRIP ELECTRODE. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Nicolet Biomedical, Inc. (Stoughton, US). The FDA issued a Cleared decision on June 24, 2002 after a review of 76 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nicolet Biomedical, Inc. devices

FDA 510(k) Submission Details - K021144

510(k) Number K021144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date June 24, 2002
Days to Decision 76 days
Submission Type Abbreviated
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
73d faster than avg
Panel avg: 149d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

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 29
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K021144.
NICOLET CORTICAL STIMULATOR
K072964 · Cardinal Health, Inc. · Dec 2008
AURAGEN CORTICAL SURFACE ELECTRODES
K082250 · Integra Neurosciences · Oct 2008
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp · May 2006
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · Ad-Tech Medical Instrument Corp · Sep 1999
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 1997
AD-TECH SUBDURAL ELECTRODE
K970587 · Ad-Tech Medical Instrument Corp · May 1997