Cleared Traditional

K912760 - AD-TECH EPIDURAL PEG ELECTRODE

K912760 is an FDA 510(k) clearance for AD-TECH EPIDURAL PEG 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 205-day FDA review.

K912760 · Ad-Tech Medical Instrument Corp · Neurology device
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Jan 1992
Decision
205d
Days
Class 2
Risk

K912760 is an FDA 510(k) clearance for the AD-TECH EPIDURAL PEG 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 January 15, 1992 after a review of 205 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.

FDA 510(k) Submission Details - K912760

510(k) Number K912760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date January 15, 1992
Days to Decision 205 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
56d slower than avg
Panel avg: 149d · This submission: 205d
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 K912760.
THE WESTERN CORTICAL ELECTRODE ARRAY
K923330 · University Hospital (London) Development Corp. · Nov 1993
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc. · Apr 1993
AD-TECH SUB DURAL ELECTRODEDS
K923803 · Ad-Tech Medical Instrument Corp · Oct 1992
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K845035 · Progress Mankind Technology · Jul 1985
WYLER SUBDURAL STRIP ELECTRODE
K850342 · Ad-Tech Medical Instrument Corp · Jul 1985