Cleared Traditional

K082474 - PMT SUBDURAL CORTICAL ELECTRODES

K082474 is the FDA 510(k) clearance for PMT SUBDURAL CORTICAL ELECTRODES by Pmt Corp.. It is a Class 2 Neurology device (product code GYC) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K082474 · Pmt Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
253d
Days
Class 2
Risk

K082474 is an FDA 510(k) clearance for the PMT SUBDURAL CORTICAL ELECTRODES. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 253 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 Pmt Corp. devices

Submission Details

510(k) Number K082474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date May 08, 2009
Days to Decision 253 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
105d slower than avg
Panel avg: 148d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - GYC Electrode, Cortical

All 15
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K082474.
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CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
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OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993