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
4745 Neurology devices
3076–3100 of 4745
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 94d
Cleared Oct 03, 2003
PLACER
K032349 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 95d
Cleared Sep 30, 2003
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · Integra Lifesciences Corp.
GXQ · Dura Substitute · 28d
Cleared Sep 25, 2003
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 43d
Cleared Sep 23, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K032553 · Cordis Neurovascular, Inc.
HCG · Device, Neurovascular Embolization · 35d
Cleared Sep 23, 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 21d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · Otto Bock Healthcare LP
GXY · Electrode, Cutaneous · 12d
Cleared Sep 22, 2003
ULTRA-DRIVE 3
K031280 · Biomet, Inc.
JDX · Instrument, Surgical, Sonic And Accessory/attachment · 153d
Cleared Sep 16, 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 29d
Cleared Sep 15, 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · Biomet, Inc.
HAW · Neurological Stereotaxic Instrument · 140d
Cleared Sep 11, 2003
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
K032561 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 22d
Cleared Sep 08, 2003
DURASIS DURAL SUBSTITUTE
K031850 · Cook Biotech, Inc.
GXQ · Dura Substitute · 84d
Cleared Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
K031694 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 88d
Cleared Aug 25, 2003
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 273d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · Image-Guided Neurologics, Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 64d
Cleared Aug 20, 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 65d
Cleared Aug 20, 2003
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc.
HCH · Clip, Aneurysm · 33d
Cleared Aug 12, 2003
CI TKR/UKR
K031770 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 64d
Cleared Aug 08, 2003
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · Synthes (Usa)
GXR · Cover, Burr Hole · 72d
Cleared Aug 01, 2003
GUGLIELMI DETACHABLE COIL (GDC)
K031049 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 121d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 166d
Cleared Jun 20, 2003
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K030963 · Cordis Neurovascular, Inc.
HCG · Device, Neurovascular Embolization · 85d
Cleared Jun 20, 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · Cardinalhealth
HCH · Clip, Aneurysm · 42d
Cleared Jun 11, 2003
VECTORVISION FLUORO3D
K024192 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 203d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 41d

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All categories 4745 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 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