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.

View all Class A Ent. devices

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
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · 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 26
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K021118.
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
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 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