Cleared Traditional

K983597 - NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

K983597 is an FDA 510(k) clearance for NEUROLINE, manufactured by Medicotest, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983597 · Medicotest, Inc. · Neurology device
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Jan 1999
Decision
90d
Days
Class 2
Risk

K983597 is an FDA 510(k) clearance for the NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Medicotest, Inc. (Washington, US). The FDA issued a Cleared decision on January 11, 1999 after a review of 90 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 Medicotest, Inc. devices

FDA 510(k) Submission Details - K983597

510(k) Number K983597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 11, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 38
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K983597.
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · Te ME NA S.A.R.L. · Aug 2000
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed · Oct 1999
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · Jack'S Electrodes · Jan 1998
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · Dantec Medical, Inc. · Mar 1996
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994