Cleared Traditional

K882053 - NICOLET EPIDURAL SPINAL ELECTRODE

K882053 is an FDA 510(k) clearance for NICOLET EPIDURAL SPINAL ELECTRODE, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K882053 · Nicolet Instrument Corp. · Neurology device
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Oct 1988
Decision
155d
Days
Class 2
Risk

K882053 is an FDA 510(k) clearance for the NICOLET EPIDURAL SPINAL ELECTRODE. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on October 18, 1988 after a review of 155 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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 Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K882053

510(k) Number K882053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date October 18, 1988
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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.