Cleared Traditional

K062880 - SUBDERMAL WIRE ELECTRODE, MODEL SWE

K062880 is an FDA 510(k) clearance for SUBDERMAL WIRE ELECTRODE, manufactured by Ives Eeg Solutions, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K062880 · Ives Eeg Solutions, Inc. · Neurology device
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Dec 2006
Decision
87d
Days
Class 2
Risk

K062880 is an FDA 510(k) clearance for the SUBDERMAL WIRE ELECTRODE, MODEL SWE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Ives Eeg Solutions, Inc. (Manotick, Ontario, CA). The FDA issued a Cleared decision on December 22, 2006 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 Ives Eeg Solutions, Inc. devices

FDA 510(k) Submission Details - K062880

510(k) Number K062880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2006
Decision Date December 22, 2006
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 28
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K062880.
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