Cleared Traditional

K924226 - OJEMANN CORTICAL STIMULATOR

K924226 is an FDA 510(k) clearance for OJEMANN CORTICAL STIMULATOR, 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 243-day FDA review.

K924226 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
243d
Days
Class 2
Risk

K924226 is an FDA 510(k) clearance for the OJEMANN CORTICAL STIMULATOR. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 243 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 Radionics, Inc. devices

FDA 510(k) Submission Details - K924226

510(k) Number K924226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1992
Decision Date April 21, 1993
Days to Decision 243 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
95d slower than avg
Panel avg: 148d · This submission: 243d
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 K924226.
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
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc. · Nov 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
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K845035 · Progress Mankind Technology · Jul 1985