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

6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1755 Neurology devices
1626–1650 of 1755
Cleared Aug 23, 1993
CORDIS TUNNELER
K932273 · Cordis Corp.
GYK · Instrument, Shunt System Implantation · 102d
Cleared Aug 20, 1993
MEDTRONIC MODEL 3990 PNS LEAD
K925952 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 269d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 225d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 191d
Cleared Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Nov 05, 1992
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
K923567 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 111d
Cleared Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K921936 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 189d
Cleared Sep 15, 1992
YASARGIL ANEURYSM CLIPS
K922272 · Aesculap, Inc.
HCH · Clip, Aneurysm · 124d
Cleared Jul 07, 1992
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
K921558 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 97d
Cleared May 20, 1992
MODELS 3987 AND 3988 RESUME LEAD FOR PNS
K920567 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 103d
Cleared Mar 11, 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · Aesculap, Inc.
HCH · Clip, Aneurysm · 202d
Cleared Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 123d
Cleared Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 175d
Cleared Feb 07, 1992
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
K913993 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 154d
Cleared Jan 22, 1992
MEDTRONIC MODEL 3586 RESUME LEAD
K913934 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 141d
Cleared Jan 22, 1992
MODEL 3587A RESUME II LEAD
K915540 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 43d
Cleared Dec 23, 1991
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 80d
Cleared Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 119d
Cleared Dec 10, 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 222d
Cleared Nov 22, 1991
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K912764 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 151d
Cleared Nov 22, 1991
MEDTRONIC 3625 SCREENER SYSTEM
K913442 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 112d
Cleared Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 167d
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · Baxter Healthcare Corp
JXG · Shunt, Central Nervous System And Components · 263d
Cleared Aug 23, 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 10d
Cleared Aug 09, 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434 · Medtronic Vascular
GZI · Stimulator, Neuromuscular, External Functional · 374d

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All categories 1755 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 HAW Neurological Stereotaxic Instrument 93 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 NRY Catheter, Thrombus Retriever 73 JXG Shunt, Central Nervous System And Components 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GWG Endoscope, Neurological 39 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27