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
4737 Neurology devices
2776–2800 of 4737
Cleared Apr 20, 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 42d
Cleared Apr 13, 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 51d
Cleared Apr 13, 2006
NORIAN CRS BONE CEMENT
K060445 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 51d
Cleared Apr 12, 2006
NEUROPROBES
K052527 · Alpha Omega Engineering , Ltd.
GZL · Electrode, Depth · 212d
Cleared Apr 10, 2006
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
K053542 · Praxim S.A
HAW · Neurological Stereotaxic Instrument · 111d
Cleared Apr 10, 2006
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · Linvatec Corp.
HBC · Motor, Drill, Electric · 68d
Cleared Apr 10, 2006
TOTAL KNEE SURGETICS NAVIGATION SYSTEM
K060282 · Praxim S.A
HAW · Neurological Stereotaxic Instrument · 66d
Cleared Apr 06, 2006
AWQ-104
K050989 · Lhasa Oms, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 352d
Cleared Mar 30, 2006
P-STIM SYSTEM
K050123 · Neuroscience Therapy Corp.
BWK · Stimulator, Electro-acupuncture · 435d
Cleared Mar 29, 2006
INTERX500 FLEXIBLE ARRAY ELECTRODE
K053626 · Neuro Resource Group, Inc.
GXY · Electrode, Cutaneous · 91d
Cleared Mar 28, 2006
ACULIFE, MODEL SMW-01
K051197 · Inno-Health Technology, Inc.
BWK · Stimulator, Electro-acupuncture · 322d
Cleared Mar 28, 2006
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
K060523 · Cyberkinetics, Inc.
OMC · Reduced- Montage Standard Electroencephalograph · 29d
Cleared Mar 23, 2006
IPLAN FLOW
K053164 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 129d
Cleared Mar 21, 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060121 · Biomet Manufacturing Corp
HAW · Neurological Stereotaxic Instrument · 63d
Cleared Mar 20, 2006
VECTORVISION HIP
K060468 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 25d
Cleared Mar 17, 2006
OSTEOPORE PCL SCAFFOLD
K051093 · Osteopore, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 323d
Cleared Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · Well-Life Healthcare Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 165d
Cleared Mar 14, 2006
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
K060368 · Inspirstar, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 29d
Cleared Mar 10, 2006
ELECTROPULSE
K051128 · Pain Relief Technologies
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 311d
Cleared Mar 10, 2006
MAGBODY DT-600
K053284 · Durtech System Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 105d
Cleared Mar 10, 2006
RT300-S, MODEL FA100052
K060032 · Restorative Therapies, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 64d
Cleared Mar 02, 2006
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052623 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 160d
Cleared Feb 27, 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K060097 · KLS-Martin L.P.
GZT · Retractor, Self-retaining, For Neurosurgery · 45d
Cleared Feb 24, 2006
ES-160
K051020 · Lhasa Oms, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 308d
Cleared Feb 13, 2006
CI KNEE, CI MI TKR
K052966 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 115d

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All categories 4737 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 JXG Shunt, Central Nervous System And Components 223 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