Cleared Abbreviated

K072964 - NICOLET CORTICAL STIMULATOR (FDA 510(k) Clearance)

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K072964 · Cardinal Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
438d
Days
Class 2
Risk

K072964 is an FDA 510(k) clearance for the NICOLET CORTICAL STIMULATOR. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Stoughton, US). The FDA issued a Cleared decision on December 30, 2008 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cardinal Health, Inc. devices

Submission Details

510(k) Number K072964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2007
Decision Date December 30, 2008
Days to Decision 438 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 148d · This submission: 438d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.