Cleared Traditional

K863135 - LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)

K863135 is an FDA 510(k) clearance for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP), manufactured by Neurotechnics, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K863135 · Neurotechnics, Inc. · Neurology device
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Sep 1987
Decision
385d
Days
Class 2
Risk

K863135 is an FDA 510(k) clearance for the LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP). Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Neurotechnics, Inc. (Annapolis, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Neurotechnics, Inc. devices

FDA 510(k) Submission Details - K863135

510(k) Number K863135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 04, 1987
Days to Decision 385 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 148d · This submission: 385d
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.

Regulatory Peers - GXZ Electrode, Needle

All 39
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K863135.
PROBLOC INSULATED NEEDLES
K926349 · Life-Tech Intl., Inc. · Jul 1993
BIO-DETEK EEG ELECTRODE
K920352 · Bio-Detek, Inc. · Aug 1992
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
K896370 · Chalgren Enterprises, Inc. · Dec 1989
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
K850107 · Nicolet Biomedical Instruments · Apr 1985
ELECTRODE, NEEDLE, CFM
K781311 · Applied Medical Research · Aug 1978