FDA Review Panel · NE

FDA 510(k) Neurology Devices

FDA 510(k) Neurology Devices - Regulatory Overview

FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.

Common categories include:

  • EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
  • Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
  • Surgical navigation systems - image-guided neurosurgery platforms
  • Intracranial pressure monitors - ICP sensors and drainage systems
  • Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery

6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4767 Neurology devices
4351–4375 of 4767
Cleared Feb 26, 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 64d
Cleared Feb 20, 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 165d
Cleared Feb 20, 1987
ARTHROSCOPIC SHOULDER HOLDER
K870212 · Dyonics, Inc.
HST · Apparatus, Traction, Non-powered · 31d
Cleared Feb 19, 1987
OBERTO MOUTH PROP
K864962 · Medovations, Inc.
JXL · Block, Bite · 59d
Cleared Feb 04, 1987
TECA/MEDELEC AS-10 SENSOR
K862906 · Teca, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 188d
Cleared Feb 04, 1987
EXTREMITY ELEVATOR
K870125 · Orthopedic Systems, Inc.
HST · Apparatus, Traction, Non-powered · 23d
Cleared Feb 03, 1987
TECA/MEDELEC AUDIOSTAR
K863156 · Teca, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 169d
Cleared Feb 03, 1987
TUPPER TROLLEY
K870102 · Orthopedic Systems, Inc.
HST · Apparatus, Traction, Non-powered · 25d
Cleared Jan 29, 1987
EVOPORT 100
K863985 · Jedmed Instrument Co.
GWJ · Stimulator, Auditory, Evoked Response · 107d
Cleared Jan 27, 1987
TECA NEUROPTO WITH OS-5 STIMULATOR
K861069 · Teca, Inc.
GWE · Stimulator, Photic, Evoked Response · 313d
Cleared Jan 20, 1987
TENZCARE(TM) SNAP ELECTRODE 6867
K864973 · 3M Company
GXY · Electrode, Cutaneous · 32d
Cleared Jan 13, 1987
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
K863175 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 148d
Cleared Jan 13, 1987
H-H SUBGALEAL TROCAR
K865075 · Holter-Hausner Intl.
GYK · Instrument, Shunt System Implantation · 15d
Cleared Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc.
IKN · Electromyograph, Diagnostic · 34d
Cleared Dec 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K864676 · American V. Mueller
JXG · Shunt, Central Nervous System And Components · 27d
Cleared Dec 22, 1986
EM TENS WINDOW ELECTRODES
K864032 · Electromed Intl., Ltd.
GXY · Electrode, Cutaneous · 68d
Cleared Dec 22, 1986
BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR
K864754 · Pudenz-Schulte Medical Research Corp.
· 17d
Cleared Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 125d
Cleared Nov 25, 1986
TRAVELER LT
K862690 · Bio-Logic Systems Corp.
GWF · Stimulator, Electrical, Evoked Response · 133d
Cleared Nov 18, 1986
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · Cadwell Laboratories, Inc.
GWE · Stimulator, Photic, Evoked Response · 259d
Cleared Nov 13, 1986
SKIN PURE
K862799 · Nihon Kohden America, Inc.
GYB · Media, Electroconductive · 114d
Cleared Oct 16, 1986
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
K860977 · Britt Corp., Inc.
LLF · Laser, Neurosurgical, Argon · 216d
Cleared Oct 06, 1986
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 392d
Cleared Oct 06, 1986
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K863749 · Teca, Inc.
GWQ · Full-montage Standard Electroencephalograph · 12d
Cleared Sep 30, 1986
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
K854533 · Madsen Electronics (Canada) , Ltd.
· 321d

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All categories 4767 HAW Neurological Stereotaxic Instrument 343 GXY Electrode, Cutaneous 311 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 286 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 143 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 102 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 72 OBP Transcranial Magnetic Stimulator 68