GXZ · Class II · 21 CFR 882.1350

FDA Product Code GXZ: Electrode, Needle

Leading manufacturers include Cadwell Laboratories, Inc., Rhythmlink International, LLC and TeDan Surgical Innovations, Inc..

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 Jul 28, 2011
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419
Stryker Spine
Neurology · 164d
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 Aug 17, 2005
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111
Excel Tech. , Ltd.
Neurology · 13d
Cleared Dec 29, 1994
EEG NEEDLE ELECTRODE
K933796
Cadwell Laboratories, Inc.
Neurology · 512d
Cleared Apr 22, 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 22, 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806
Cadwell Laboratories, Inc.
Neurology · 261d
Cleared Apr 19, 1994
GROUND/REFERENCE NEEDLE ELECTRODE
K933793
Cadwell Laboratories, Inc.
Neurology · 258d
Cleared Jul 29, 1993
PROBLOC INSULATED NEEDLES
K926349
Life-Tech Intl., Inc.
Neurology · 224d

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 →