Cleared Special

K111737 - DISPOSABLE ELECTRODE

K111737 is an FDA 510(k) clearance for DISPOSABLE ELECTRODE, manufactured by Sanibel Supply. The device is a Class 2 Neurology device with product code GXY cleared through the Special 510(k) pathway after a 115-day FDA review.

K111737 · Sanibel Supply · Neurology device
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Oct 2011
Decision
115d
Days
Class 2
Risk

K111737 is an FDA 510(k) clearance for the DISPOSABLE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Sanibel Supply (Assens, DK). The FDA issued a Cleared decision on October 14, 2011 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sanibel Supply devices

FDA 510(k) Submission Details - K111737

510(k) Number K111737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date October 14, 2011
Days to Decision 115 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 230
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K111737.
SENSUS ELECTRODE
K121816 · Neurometrix, Inc. · Nov 2012
LONG LIFE PADTM
K120516 · Omron Healthcare, Inc. · May 2012
NEUROTECH RECOVERY
K112934 · Bio-Medical Research, Ltd. · Jan 2012
REUSABLE STIMULATING ELECTRODES
K111270 · Bio Protech, Inc. · Sep 2011
LIFECARE CONDUCTIVE GARMENTS
K103719 · Everyway Medical Instruments Co.,Ltd · Aug 2011
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
K102614 · Bio-Medical Research, Ltd. · Jun 2011