Cleared Abbreviated

STERILE SUBDERMAL NEEDLE ELECTRODES (K010019) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K010019 · Nicolet Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
76d
Days
Class 2
Risk

K010019 is an FDA 510(k) clearance for the STERILE SUBDERMAL NEEDLE ELECTRODES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Nicolet Biomedical, Inc. (Stoughton, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 76 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nicolet Biomedical, Inc. devices

Submission Details

510(k) Number K010019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date March 19, 2001
Days to Decision 76 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 52
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