Cleared Traditional

K111717 - ELECTRO-GEL

K111717 is the FDA 510(k) clearance for ELECTRO-GEL by Electro-Cap Intl., Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K111717 · Electro-Cap Intl., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
199d
Days
Class 2
Risk

K111717 is an FDA 510(k) clearance for the ELECTRO-GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Electro-Cap Intl., Inc. (Eaton, US). The FDA issued a Cleared decision on January 5, 2012 after a review of 199 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Electro-Cap Intl., Inc. devices

Submission Details

510(k) Number K111717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date January 05, 2012
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 148d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 29
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K111717.
Elefix V Paste for EEG & EMG
K191975 · Nihon Kohden Corporation · Feb 2020
SAC2 - Electrode Cream
K192606 · Spes Medica Srl · Jan 2020
Tech Dots - Adhesive and conductive gel
K190050 · Spes Medica Srl · Jul 2019
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994