Cleared Traditional

K970587 - AD-TECH SUBDURAL ELECTRODE

K970587 is an FDA 510(k) clearance for AD-TECH SUBDURAL ELECTRODE, 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 80-day FDA review.

K970587 · Ad-Tech Medical Instrument Corp · Neurology device
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May 1997
Decision
80d
Days
Class 2
Risk

K970587 is an FDA 510(k) clearance for the AD-TECH SUBDURAL ELECTRODE. 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 May 9, 1997 after a review of 80 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.

View all Ad-Tech Medical Instrument Corp devices

FDA 510(k) Submission Details - K970587

510(k) Number K970587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date May 09, 1997
Days to Decision 80 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
68d faster than avg
Panel avg: 148d · This submission: 80d
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 20
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K970587.
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp · May 2006
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · Ad-Tech Medical Instrument Corp · Sep 1999
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 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
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993