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
4728 Neurology devices
2601–2625 of 4728
Cleared Jul 19, 2007
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 22d
Cleared Jul 18, 2007
SMARTEP, MODEL M010000
K070608 · Intelligent Hearing Systems
GWJ · Stimulator, Auditory, Evoked Response · 135d
Cleared Jul 16, 2007
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
K070299 · Ezfit Technology, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 166d
Cleared Jul 12, 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 27d
Cleared Jul 12, 2007
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
K071640 · Cook, Inc.
NHC · Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) · 27d
Cleared Jul 06, 2007
WELLNESSPRO 2010
K062616 · Intelsource Group, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 304d
Cleared Jul 05, 2007
PRESSIO ICP MONITORING SYSTEM
K062584 · Sophysa SA
GWM · Device, Monitoring, Intracranial Pressure · 307d
Cleared Jul 05, 2007
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
K071113 · Restorative Therapies, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 76d
Cleared Jul 02, 2007
CRANIAL SOLUTION ORTHOSIS
K063133 · Cranial Solutions
MVA · Orthosis, Cranial · 262d
Cleared Jul 02, 2007
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc.
HAW · Neurological Stereotaxic Instrument · 52d
Cleared Jun 29, 2007
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
K070696 · Interacoustics A/S
GWJ · Stimulator, Auditory, Evoked Response · 108d
Cleared Jun 29, 2007
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890 · Everlife Medical Equipment Co., Ltd.
LIH · Interferential Current Therapy · 91d
Cleared Jun 20, 2007
GFX NERVE ABLATION SYSTEM
K063753 · Aci, Inc.
GXD · Generator, Lesion, Radiofrequency · 183d
Cleared Jun 18, 2007
BIS EEG MONITOR VIEW
K062613 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 286d
Cleared Jun 15, 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 98d
Cleared Jun 15, 2007
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K070901 · Bioplate, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 74d
Cleared Jun 14, 2007
STOCKERT NEURO N50, MODEL12267
K070336 · Stockert GmbH
GXD · Generator, Lesion, Radiofrequency · 129d
Cleared Jun 13, 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation
HBL · Holder, Head, Neurosurgical (skull Clamp) · 19d
Cleared Jun 07, 2007
SACS EEG WORKSTATION A7
K071109 · Sacs Medical AB
GWQ · Full-montage Standard Electroencephalograph · 50d
Cleared Jun 01, 2007
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
K071246 · Micrus Endovascular Corporation
HCG · Device, Neurovascular Embolization · 29d
Cleared Jun 01, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071358 · Radiant Medical
NCX · System, Hypothermia, Intravenous, Cooling · 17d
Cleared May 30, 2007
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S
GXZ · Electrode, Needle · 30d
Cleared May 29, 2007
FLEX ARM RETRACTOR SYSTEM
K071338 · Koros USA, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 15d
Cleared May 25, 2007
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
K071173 · Ossur Americans (Formerly the Jerome Group)
HAX · Tong, Skull For Traction · 28d
Cleared May 24, 2007
RHYTHM TOUCH Q 2-WAY
K063743 · Shockim Enterprises, Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 157d

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All categories 4728 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 278 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 141 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