Cleared Traditional

K924226 - OJEMANN CORTICAL STIMULATOR

K924226 is the FDA 510(k) clearance for OJEMANN CORTICAL STIMULATOR by Radionics, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

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 14
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K924226.
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802 · Integra LifeSciences Corporation · Nov 2010
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 1997
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc. · Nov 1993