Neurology— FDA advisory panel NE
6,150 FDA 510(k) clearances across 184 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
Neurology spans diagnostics and a fast-moving therapeutic edge: EEG systems and electrodes, nerve-conduction and evoked-potential instruments, intracranial pressure monitors, transcranial magnetic stimulators, external nerve stimulators for pain and migraine, and cranial fixation hardware. Like cardiology, the panel's deepest implants — deep-brain stimulation systems, most notably — are PMA devices and invisible in 510(k) data.
What the clearance record captures well is the non-invasive neurotech expansion: external stimulation and neurodiagnostic wearables have broadened the applicant base far beyond the traditional neurodiagnostics manufacturers. It also captures the software edge — quantitative EEG analysis and stroke-triage software clear as neurological devices (though some imaging-based tools file under radiology instead, so searches for "neuro AI" should cover both panels).
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the Neurology panel
all codes- GZJ — STIMPOD NMS460 Nerve Stimulator
- OLO — GPS Ankle
- GXY — Rongjian Self-adhesive Electrode
- HAW — NeuroAlign
- JXG — Ventricular Catheters, Thomale Catheter
- NUH — Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
- GWQ — Enobio Dx (3 models)
- HCG — MICRUSFRAME (19+ models)
- HCC — AesyBite Active
- GWF — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- GZB — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- GWM — Pressio 3 Multi-parameter Neuromonitoring System
- GWG — cCeLL - In vivo
- NFO — FAQ (FAQ 401); FAQ (FAQ 402)
- GWJ — Integrity V500 (Integrity, Integrity with VEMP)
Recent clearances in the Neurology panel
all clearancesData sourced from openFDA. This site is unofficial and independent of the FDA.