Cleared Traditional

K083350 - TENS/NMES/FES STIMULATING ELECTRODE

K083350 is an FDA 510(k) clearance for TENS/NMES/FES STIMULATING ELECTRODE, manufactured by Covidien LP. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K083350 · Covidien LP · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
159d
Days
Class 2
Risk

K083350 is an FDA 510(k) clearance for the TENS/NMES/FES STIMULATING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Covidien LP (Mansfield, US). The FDA issued a Cleared decision on April 21, 2009 after a review of 159 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 - K083350

510(k) Number K083350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date April 21, 2009
Days to Decision 159 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 149d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 355
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K083350.
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