Cleared Special

K021118 - DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

K021118 is an FDA 510(k) clearance for DETACHABLE MONOPOLAR EMG NEEDLE, manufactured by Class A Ent.. The device is a Class 2 Neurology device with product code GXZ cleared through the Special 510(k) pathway after a 50-day FDA review.

K021118 · Class A Ent. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
50d
Days
Class 2
Risk

K021118 is an FDA 510(k) clearance for the DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 6.... Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Class A Ent. (Hesperia, US). The FDA issued a Cleared decision on May 28, 2002 after a review of 50 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021118

510(k) Number K021118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date May 28, 2002
Days to Decision 50 days
Submission Type Special
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
99d faster than avg
Panel avg: 149d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K021118.
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
K023472 · Class A Enterprises, Inc. · Mar 2003
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K020910 · The Electrode Store, Inc. · Jul 2002
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · Nicolet Biomedical, Inc. · Mar 2001
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · Te ME NA S.A.R.L. · Aug 2000
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed · Oct 1999
K021118 · DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
Download PDF Class A Ent.