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
4763 Neurology devices
4151–4175 of 4763
Cleared Jan 30, 1991
MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER
K904409 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 126d
Cleared Jan 18, 1991
SYNAPS (TM)
K903828 · Henley Intl.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 150d
Cleared Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 129d
Cleared Nov 16, 1990
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
K896825 · Infrasonics Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 346d
Cleared Nov 15, 1990
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc.
GWQ · Full-montage Standard Electroencephalograph · 129d
Cleared Nov 13, 1990
HILAL EMBOLIZATION MICROCOIL(TM)
K901337 · Cook, Inc.
HCG · Device, Neurovascular Embolization · 236d
Cleared Oct 26, 1990
MEGA-TENS DUAL CHANNEL T.E.N.S.
K903017 · Futuremed Div. of Future Impex Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 108d
Cleared Oct 09, 1990
M(3):MICRO MUSCLE MONITOR
K896409 · Thought Technology , Ltd.
HCC · Device, Biofeedback · 336d
Cleared Oct 09, 1990
ACCU-FLO* UNITIZED SHUNT
K904120 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 33d
Cleared Oct 05, 1990
SMS-712NA
K903085 · Toshiba America Medical Systems, In.C
GXW · Echoencephalograph · 85d
Cleared Oct 03, 1990
PS MEDICAL CRANIAL HAND DRILL
K904283 · Pudenz-Schulte Medical Research Corp.
HBG · Drills, Burrs, Trephines & Accessories (manual) · 16d
Cleared Oct 01, 1990
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · Chattanooga Group, Inc.
LBB · Dynamometer, Ac-powered · 195d
Cleared Sep 20, 1990
SUNDT AVM MICRO CLIP
K902544 · Codman & Shurtleff, Inc.
HCI · Applier, Aneurysm Clip · 106d
Cleared Sep 13, 1990
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · Micro-Aire Surgical Instruments, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 30d
Cleared Sep 04, 1990
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
K900472 · Skytron, Div. the Kmw Group, Inc.
HBN · Chair, Neurosurgical · 216d
Cleared Aug 17, 1990
NORTECH MODEL 86901000 ELECTRODE
K903427 · Andover Medical, Inc.
GXY · Electrode, Cutaneous · 17d
Cleared Aug 08, 1990
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
K902783 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 43d
Cleared Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 59d
Cleared Jul 19, 1990
SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT
K902719 · Labeltape Meditect, Inc.
GXY · Electrode, Cutaneous · 29d
Cleared Jul 16, 1990
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl.
GYB · Media, Electroconductive · 98d
Cleared Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories
GWM · Device, Monitoring, Intracranial Pressure · 592d
Cleared Jul 03, 1990
MODIFIED TARGET THERAPEUTICS COILS
K901721 · Target Therapeutics
HCG · Device, Neurovascular Embolization · 81d
Cleared Jul 03, 1990
DOBBHOFF(R) RETRIEVAL FORCEPS
K901744 · Biosearch Medical Products, Inc.
KQW · Goniometer, Nonpowered · 77d
Cleared Jun 18, 1990
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · Dantec Medical, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 192d
Cleared Jun 08, 1990
TBD TENS REUSABLE ELECTRODE
K902195 · Empi
GXY · Electrode, Cutaneous · 23d

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All categories 4763 HAW Neurological Stereotaxic Instrument 343 GXY Electrode, Cutaneous 309 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 285 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