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

6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
2501–2525 of 6334
Cleared Dec 07, 2009
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K092793 · Bio-Medical Research, Ltd.
GXY · Electrode, Cutaneous · 87d
Cleared Dec 04, 2009
EMSI GARMENT ELECTRODES
K090889 · Emsi
GXY · Electrode, Cutaneous · 248d
Cleared Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · Integra Lifesciences Corp.
JXG · Shunt, Central Nervous System And Components · 106d
Cleared Nov 17, 2009
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
K092239 · Medtech S.A
HAW · Neurological Stereotaxic Instrument · 117d
Cleared Nov 16, 2009
KRYPTONITE BONE CEMENT
K091382 · Doctors Research Group, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 189d
Cleared Nov 06, 2009
VIGILANT EEG MONITOR, VIGILANT 2.0
K091963 · Infinite Biomedical Technologies, LLC
OLT · Non-normalizing Quantitative Electroencephalograph Software · 128d
Cleared Oct 23, 2009
AMD 6605 TENS/NMES
K092990 · Advantageous Medical Devices, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 25d
Cleared Oct 23, 2009
BIS QUATRO SENSOR
K093183 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 14d
Cleared Oct 21, 2009
NEUROCALM MODEL 1 AND 2
K090866 · Neuromed Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 204d
Cleared Oct 16, 2009
IDENTEVENT, VERSION 1.0G
K092039 · Optima Neuroscience, Inc.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 102d
Cleared Oct 16, 2009
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 73d
Cleared Oct 09, 2009
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
K090190 · Nuclemed S.A.
HAW · Neurological Stereotaxic Instrument · 256d
Cleared Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · Well-Life Healthcare Limited
LIH · Interferential Current Therapy · 29d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
K092666 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 30d
Cleared Sep 29, 2009
SYNERGY
K083378 · Innerspace, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 319d
Cleared Sep 25, 2009
SONOWAND INVITE
K083597 · Sonowand AS
HAW · Neurological Stereotaxic Instrument · 294d
Cleared Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
K090752 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 185d
Cleared Sep 18, 2009
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
K092562 · FHC, Inc.
HAW · Neurological Stereotaxic Instrument · 29d
Cleared Sep 11, 2009
UROVAL BRS SYSTEM, MODEL BRS01
K083679 · Uroval
IKN · Electromyograph, Diagnostic · 274d
Cleared Sep 08, 2009
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921 · Codman & Shurtleff, Inc.
HCH · Clip, Aneurysm · 70d
Cleared Sep 03, 2009
ICS CHARTR EP 200
K092373 · Gn Otometrics
GWJ · Stimulator, Auditory, Evoked Response · 29d
Cleared Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K091312 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 121d
Cleared Aug 18, 2009
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
K083250 · Aa Neuromed Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 287d
Cleared Aug 14, 2009
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
K083758 · The Electrode Store, Inc.
GXY · Electrode, Cutaneous · 240d
Cleared Aug 11, 2009
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
K090342 · Sophysa SA
JXG · Shunt, Central Nervous System And Components · 182d

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All categories 6334 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 605 GXY Electrode, Cutaneous 438 HAW Neurological Stereotaxic Instrument 417 JXG Shunt, Central Nervous System And Components 260 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 218 GWQ Full-montage Standard Electroencephalograph 189 HCG Device, Neurovascular Embolization 187 HCC Device, Biofeedback 172 GWF Stimulator, Electrical, Evoked Response 140 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 133 NRY Catheter, Thrombus Retriever 117 GWM Device, Monitoring, Intracranial Pressure 105 QJP Catheter, Percutaneous, Neurovasculature 102 GWG Endoscope, Neurological 94 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 81