Cleared Traditional

K923803 - AD-TECH SUB DURAL ELECTRODEDS

K923803 is an FDA 510(k) clearance for AD-TECH SUB DURAL ELECTRODEDS, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K923803 · Ad-Tech Medical Instrument Corp · Neurology device
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Oct 1992
Decision
86d
Days
Class 2
Risk

K923803 is an FDA 510(k) clearance for the AD-TECH SUB DURAL ELECTRODEDS. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K923803

510(k) Number K923803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1992
Decision Date October 23, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 149d · This submission: 86d
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 30
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K923803.
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc. · Nov 1993
THE WESTERN CORTICAL ELECTRODE ARRAY
K923330 · University Hospital (London) Development Corp. · Nov 1993
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993
AD-TECH EPIDURAL PEG ELECTRODE
K912760 · Ad-Tech Medical Instrument Corp · Jan 1992
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K845035 · Progress Mankind Technology · Jul 1985
WYLER SUBDURAL STRIP ELECTRODE
K850342 · Ad-Tech Medical Instrument Corp · Jul 1985