Cleared Traditional

ELECTRO-GEL (K111717) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111717 · Electro-Cap Intl., Inc. · Neurology device
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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 68
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