Cleared Traditional

K850107 - CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE

K850107 is an FDA 510(k) clearance for CONCENTRIC NEEDLE ELECTRODES-VARIOUS SI..., manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K850107 · Nicolet Biomedical Instruments · Neurology device
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Apr 1985
Decision
91d
Days
Class 2
Risk

K850107 is an FDA 510(k) clearance for the CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 91 days - within the typical 510(k) review window.

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: 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 Biomedical Instruments devices

FDA 510(k) Submission Details - K850107

510(k) Number K850107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1985
Decision Date April 11, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
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.