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
4747 Neurology devices
3151–3175 of 4747
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 24d
Cleared Aug 13, 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599 · Excel Tech. , Ltd.
GWQ · Full-montage Standard Electroencephalograph · 90d
Cleared Jul 29, 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 171d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408 · Synthes (Usa)
GXR · Cover, Burr Hole · 87d
Cleared Jul 29, 2002
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 74d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 70d
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · Nihon Kohden America, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 28d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · Aesculap, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jul 25, 2002
CLARREN HELMET (ORTHOMERICA)
K021918 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 44d
Cleared Jul 19, 2002
KOLIBRI IGS SYSTEMS
K014256 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 205d
Cleared Jul 11, 2002
NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 217d
Cleared Jul 09, 2002
STARLIGHT
K021207 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 84d
Cleared Jul 09, 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 28d
Cleared Jul 01, 2002
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 21d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 86d
Cleared Jun 18, 2002
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · Olympic Medical Corp.
OMC · Reduced- Montage Standard Electroencephalograph · 137d
Cleared Jun 14, 2002
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc.
HAW · Neurological Stereotaxic Instrument · 182d
Cleared Jun 12, 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 14d
Cleared Jun 06, 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 28d
Cleared Jun 06, 2002
PAINDOC
K021518 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 27d
Cleared Jun 03, 2002
NAVIPRO
K020764 · Kinamed, Inc.
HAW · Neurological Stereotaxic Instrument · 88d
Cleared May 20, 2002
GALILEO CAS/NAV TKR SYSTEM
K020298 · Plus Orthopedics
HAW · Neurological Stereotaxic Instrument · 112d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 70d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 28d
Cleared May 03, 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354 · Baylis Medical Co., Inc.
GXD · Generator, Lesion, Radiofrequency · 88d

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All categories 4747 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 280 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 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 100 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67