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
4764 Neurology devices
4251–4275 of 4764
Cleared Dec 02, 1988
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
K884412 · Valleylab, Inc.
LBK · Neurosurgical Ultrasonic Instruments · 43d
Cleared Dec 02, 1988
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
K884413 · Valleylab, Inc.
LBK · Neurosurgical Ultrasonic Instruments · 43d
Cleared Nov 30, 1988
XTREL, MODEL NUMBER 3425
K883780 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 85d
Cleared Nov 17, 1988
DYNAMIC CRUCIATE TESTER
K881876 · Dyonics, Inc.
LYH · Arthrometer · 197d
Cleared Nov 16, 1988
MYODAC
K883597 · Thought Technology , Ltd.
HCC · Device, Biofeedback · 86d
Cleared Oct 07, 1988
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · New England Surgical Instrument Corp.
HBO · Clip, Scalp · 17d
Cleared Sep 30, 1988
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc.
GWL · Amplifier, Physiological Signal · 196d
Cleared Sep 30, 1988
HEPAX (TENS)
K882154 · Avl Scientific Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 130d
Cleared Sep 30, 1988
MULTIDAY, MODELS 8300 AND 8310
K882888 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 81d
Cleared Sep 30, 1988
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607 · Codman & Shurtleff, Inc.
GYK · Instrument, Shunt System Implantation · 38d
Cleared Sep 29, 1988
PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535
K882886 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 80d
Cleared Sep 29, 1988
PROGEL(TM), MODELS 8630 AND 8635
K882887 · Medical Devices, Inc.
GXY · Electrode, Cutaneous · 80d
Cleared Sep 26, 1988
MYOTRAC
K881416 · Thought Technology , Ltd.
HCC · Device, Biofeedback · 175d
Cleared Sep 22, 1988
EMPI MODEL 727,NMS
K882631 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 87d
Cleared Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616 · Progress Mankind Technology
JXG · Shunt, Central Nervous System And Components · 150d
Cleared Aug 29, 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 52d
Cleared Aug 29, 1988
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp.
GWM · Device, Monitoring, Intracranial Pressure · 35d
Cleared Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · Pmt Corp.
JXG · Shunt, Central Nervous System And Components · 30d
Cleared Aug 17, 1988
STORZ DISPOSABLE BIPOLAR PENCILS
K882802 · Storz Instrument Co.
GXI · Probe, Radiofrequency Lesion · 41d
Cleared Jul 18, 1988
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular
GXY · Electrode, Cutaneous · 84d
Cleared Jul 14, 1988
H-H FLUSHING RESERVOIR
K875287 · Holter-Hausner Intl.
JXG · Shunt, Central Nervous System And Components · 198d
Cleared Jun 24, 1988
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
K875042 · Surgilase, Inc.
LKW · Laser, Neurosurgical · 200d
Cleared Jun 17, 1988
ORTHOPAEDIC AND SPINAL RING CURRETTES
K882072 · Karlin Technology, Inc.
JXH · Methyl Methacrylate For Aneurysmorrhaphy · 31d
Cleared Jun 16, 1988
SPARE MS 700 TENS ELECTRODE
K881871 · Lectec Corp.
GXY · Electrode, Cutaneous · 44d
Cleared Jun 16, 1988
TENS ELECTRODE MODEL 238P
K881872 · Lectec Corp.
GXY · Electrode, Cutaneous · 44d

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All categories 4764 HAW Neurological Stereotaxic Instrument 343 GXY Electrode, Cutaneous 309 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 285 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 143 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 102 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 72 OBP Transcranial Magnetic Stimulator 68