Product code GXZ— Neurology
PRESSON ELECTRODE
- Classification name
- Electrode, Needle
- Device class
- Class 2
- Regulation
- 21 CFR 882.1350
- Advisory panel
- Neurology
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code GXZ
FDA has cleared devices under product code GXZ between 1978 and 2024, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2020
- 2019
- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
Top applicants under product code GXZ
Recent clearances under product code GXZ
- K241045 — Disposable Subdermal Needle Electrode, Corkscrew
- K232581 — Medical Disposable Sterile Needle Electrode
- K231691 — Phantom XL Insulated Dilators
- K200984 — Guardian Needle Electrode
- K192603 — Spes Medica Subdermal Needle Electrodes
- K190801 — PressOn Electrode Headset
- K161566 — DMS Disposable Subdermal Needle Electrodes
- K142470 — E-Shield Multi-paried Subdermal Needle Electrodes
- K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
- K130220 — MR CONDITIONAL PRESSON ELECTRODE
- K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
- K121347 — PRESSON ELECTRODE
- K103103 — PRESSON ELECTRODE
- K110419 — AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
- K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
- K073229 — NERVE MONITORING CABLE
- K072276 — SUBDERMAL NEEDLE ELECTRODES
- K063729 — DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
- K071185 — MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
- K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
- K062880 — SUBDERMAL WIRE ELECTRODE, MODEL SWE
- K060189 — PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
- K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
- K050325 — DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
- K050194 — AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
- K040639 — ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
- K023472 — LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
- K022914 — RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
- K020910 — SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
- K021118 — DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
- K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES
- K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
- K990793 — ACCUGUIDE MUSCLE INJECTION MONITOR
- K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
- K974119 — DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
- K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
- K926094 — PROTECTRODE SYSTEM
- K934779 — AGRAM SPYRAL ELECTRODE
- K933796 — EEG NEEDLE ELECTRODE
- K933795 — CONCENTRIC EMG NEEDLE ELECTRODE
- K933806 — MONOPOLAR EMG NEEDLE ELECTRODE
- K933793 — GROUND/REFERENCE NEEDLE ELECTRODE
- K926349 — PROBLOC INSULATED NEEDLES
- K920352 — BIO-DETEK EEG ELECTRODE
- K912783 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
- K894911 — SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
- K900740 — SPECIMEX DC
- K901280 — DISPOSIBLE EEG NEEDLE ELECTRODES
- K896370 — DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
- K863135 — LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)
- K863136 — HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
- K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
- K781311 — ELECTRODE, NEEDLE, CFM
Data sourced from openFDA. This site is unofficial and independent of the FDA.