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

4752 Neurology devices

3701–3725 of 4752

Cleared Mar 21, 1997

TRUFILL PVA PARTICLES

K965174 · Cordis Neurovascular, Inc.

HCG · Device, Neurovascular Embolization · 87d

Cleared Mar 19, 1997

EXTRA TENS (RI-2500) NEO TENS (RI-2000E)

K963507 · Comtek Intl., Corp.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 197d

Cleared Mar 19, 1997

STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE

K964224 · Pmt Corp.

GYC · Electrode, Cortical · 147d

Cleared Mar 19, 1997

K964737 · D.O. Weaver Co.

GYB · Media, Electroconductive · 114d

Cleared Mar 18, 1997

K970696 · Lsi Intl., Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 21d

Cleared Mar 12, 1997

K965182 · Radionics, Inc.

GXD · Generator, Lesion, Radiofrequency · 78d

Cleared Mar 06, 1997

SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.

K965070 · Mecta Corp.

QGH · Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder · 85d

Cleared Mar 06, 1997

2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS

K965078 · Neuro Navigational Corp.

GWG · Endoscope, Neurological · 77d

Cleared Mar 06, 1997

MEDICOM, TENS ELECTRODES

K965194 · Medicotest A/S

GXY · Electrode, Cutaneous · 72d

Cleared Feb 26, 1997

SHE-LI TENS STIMULATOR MODEL SL-101 RX

K961809 · Medi Consultants, Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 292d

Cleared Feb 26, 1997

GALILEO EVOKED POTENTIALRE

K963662 · Biosound, Inc.

GWF · Stimulator, Electrical, Evoked Response · 166d

Cleared Feb 21, 1997

K960097 · Ics Medical Corp.

GWJ · Stimulator, Auditory, Evoked Response · 407d

Cleared Feb 13, 1997

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

K963729 · Skylark Device Co., Ltd.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 150d

Cleared Feb 06, 1997

M AND R REUSABLE ELECTRODES (MULTIPLE)

K963125 · M & R Mfg., Inc.

GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 178d

Cleared Feb 05, 1997

SUGITA AVM MICROCLIP

K960037 · Mizuho America, Inc.

HCH · Clip, Aneurysm · 399d

Cleared Feb 05, 1997

AT 62 EEG (A.K.A THE A

K965006 · Stoelting Co.

HCC · Device, Biofeedback · 51d

Cleared Feb 03, 1997

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)

K964933 · Mekanika, Inc.

LBB · Dynamometer, Ac-powered · 55d

Cleared Jan 31, 1997

SHUNT TAP WITH ICP MONITORING ACCESS PORT

K964371 · Integra Neurocare, LLC

JXG · Shunt, Central Nervous System And Components · 91d

Cleared Jan 31, 1997

RADIONICS CONTOUR FLEX PLUS VALVE

K964386 · Radionics, Inc.

JXG · Shunt, Central Nervous System And Components · 88d

Cleared Jan 30, 1997

CES VASCULAR OCCLUSION SYSTEM

K964367 · Cordis Neurovascular, Inc.

HCG · Device, Neurovascular Embolization · 90d

Cleared Jan 27, 1997

K964280 · Medelec , Ltd.

GWQ · Full-montage Standard Electroencephalograph · 91d

Cleared Jan 27, 1997

AQUABOND ELECTRODE

K964433 · Medibond , Ltd.

GXY · Electrode, Cutaneous · 83d

Cleared Jan 27, 1997

K964685 · John Chatillon & Sons, Inc.

LBB · Dynamometer, Ac-powered · 66d

Cleared Jan 24, 1997

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

K964537 · Osteogenics, Inc.

GXP · Methyl Methacrylate For Cranioplasty · 73d

Cleared Jan 23, 1997

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

K964402 · V. Mueller Neuro/Spine

GZT · Retractor, Self-retaining, For Neurosurgery · 80d

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