Cleared Traditional

K926424 - CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON

K926424 is an FDA 510(k) clearance for CORTICAL SURF EPILEPSY ELECT DEPTH ELEC..., manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K926424 · Radionics, Inc. · Neurology device
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Nov 1993
Decision
331d
Days
Class 2
Risk

K926424 is an FDA 510(k) clearance for the CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on November 19, 1993 after a review of 331 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 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. Elevated predicate reliance profile. 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 Radionics, Inc. devices

FDA 510(k) Submission Details - K926424

510(k) Number K926424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date November 19, 1993
Days to Decision 331 days
Submission Type Traditional
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
183d slower than avg
Panel avg: 148d · This submission: 331d
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 28
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K926424.
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
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
K964224 · Pmt Corp. · Mar 1997
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993
AD-TECH SUB DURAL ELECTRODEDS
K923803 · Ad-Tech Medical Instrument Corp · Oct 1992
AD-TECH EPIDURAL PEG ELECTRODE
K912760 · Ad-Tech Medical Instrument Corp · Jan 1992