GXZ · Class II · 21 CFR 882.1350

FDA Product Code GXZ: Electrode, Needle

Leading manufacturers include Rhythmlink International, LLC, Cadwell Laboratories, Inc. and Technomed Europe.

53
Total
53
Cleared
194d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 238d recently vs 194d historically

FDA 510(k) Cleared Electrode, Needle Devices (Product Code GXZ)

53 devices
1–24 of 53
Cleared Dec 11, 2024
Disposable Subdermal Needle Electrode, Corkscrew
K241045
Technomed Europe
Neurology · 238d
Cleared Dec 04, 2023
Medical Disposable Sterile Needle Electrode
K232581
Suzhou Haishen Medical Device Associates Co., Ltd.
Neurology · 101d
Cleared Jun 29, 2023
Phantom XL Insulated Dilators
K231691
TeDan Surgical Innovations, Inc.
Neurology · 20d
Cleared May 27, 2020
Guardian Needle Electrode
K200984
Rhythmlink International, LLC
Neurology · 43d
Cleared Nov 22, 2019
Spes Medica Subdermal Needle Electrodes
K192603
Spes Medica Srl
Neurology · 63d
Cleared Jul 10, 2019
PressOn Electrode Headset
K190801
Rhythmlink International, LLC
Neurology · 103d
Cleared Dec 21, 2016
DMS Disposable Subdermal Needle Electrodes
K161566
Daehan Medical Systems Co., Ltd.
Neurology · 198d
Cleared Nov 05, 2014
E-Shield Multi-paried Subdermal Needle Electrodes
K142470
Neuroinvent, Inc.
Neurology · 63d
Cleared Jul 18, 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200
Neuroinvent, Inc.
Neurology · 172d
Cleared Jul 22, 2013
MR CONDITIONAL PRESSON ELECTRODE
K130220
Rhythmlink International, LLC
Neurology · 174d
Cleared Jul 19, 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
K130136
Technomed Europe
Neurology · 182d
Cleared Jul 12, 2012
PRESSON ELECTRODE
K121347
Rhythmlink International, LLC
Neurology · 72d
Cleared Jul 28, 2011
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419
Stryker Spine
Neurology · 164d
Cleared Aug 19, 2010
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
K100912
Kirwan Surgical Products, Inc.
Neurology · 140d
Cleared Jun 06, 2008
NERVE MONITORING CABLE
K073229
Pioneer Surgical Technology
Neurology · 204d
Cleared May 30, 2007
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185
Ambu A/S
Neurology · 30d
Cleared Jan 12, 2007
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
K062996
Axon Systems, Inc.
Neurology · 102d
Cleared Dec 22, 2006
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880
Ives Eeg Solutions, Inc.
Neurology · 87d
Cleared May 30, 2006
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
K060189
Ives Eeg Solutions, Inc.
Neurology · 126d
Cleared Aug 17, 2005
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111
Excel Tech. , Ltd.
Neurology · 13d
Cleared May 05, 2005
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
K050325
Technomed Europe
Neurology · 85d
Cleared Apr 26, 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194
Axon Systems, Inc.
Neurology · 89d
Cleared Dec 20, 2002
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914
Rhythmlink International, LLC
Neurology · 108d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100
Te ME NA S.A.R.L.
Neurology · 576d

About Product Code GXZ - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code GXZ since 1978, with 53 receiving FDA clearance (average review time: 194 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - GXZ Product Code

Recent submissions under GXZ have taken an average of 238 days to reach a decision - up from 194 days historically. Manufacturers should account for longer review timelines in current project planning.

GXZ devices are reviewed by the Neurology panel. Browse all Neurology devices →