Cleared Traditional

K082629 - S12X WITH ESAX OPTION

K082629 is an FDA 510(k) clearance for S12X WITH ESAX OPTION, manufactured by Chatten Associates, Inc.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K082629 · Chatten Associates, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
295d
Days
Class 2
Risk

K082629 is an FDA 510(k) clearance for the S12X WITH ESAX OPTION. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Chatten Associates, Inc. (West Conshohocken, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 295 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chatten Associates, Inc. devices

FDA 510(k) Submission Details - K082629

510(k) Number K082629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date July 01, 2009
Days to Decision 295 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 148d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 25
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K082629.
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NICOLET CORTICAL STIMULATOR
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DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp · May 2006