Cleared Traditional

K983597 - NEUROLINE

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

K983597 · Medicotest, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 15
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K983597.
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · Cadwell Laboratories, Inc. · Apr 1994