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
1601–1625 of 1755
Cleared Jul 28, 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 332d
Cleared May 18, 1995
RIB RESECTOR
K951492 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 48d
Cleared Apr 19, 1995
TECOTHANE 55D
K950425 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 76d
Cleared Apr 12, 1995
MODEL 3470 X-TREL RF RECEIVER
K943537 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 264d
Cleared Mar 01, 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp.
GWM · Device, Monitoring, Intracranial Pressure · 379d
Cleared Feb 14, 1995
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K934065 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 543d
Cleared Feb 03, 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K945572 · Johnson & Johnson Professionals, Inc.
GWG · Endoscope, Neurological · 81d
Cleared Jan 30, 1995
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K950127 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 18d
Cleared Jan 24, 1995
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970 · Aesculap, Inc.
HCI · Applier, Aneurysm Clip · 328d
Cleared Jan 11, 1995
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K945103 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 85d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc
HAE · Rongeur, Manual · 30d
Cleared Jul 25, 1994
AUTO SUTURE PITUITARY SPINAL RONGEUR
K943115 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 28d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 426d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL CURETTE
K942967 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL OSTEOTOME
K942968 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL NERVE HOOK
K942969 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · United States Surgical, A Division of Tyco Healthc
HAO · Instrument, Surgical, Non-powered · 30d
Cleared Jul 18, 1994
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K940416 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 171d
Cleared Jul 11, 1994
NEUROLOGICAL LEAD ACCESSORIES
K936099 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 201d
Cleared Jul 11, 1994
AESCULAP NEUROENDOSCOPE
K941239 · Aesculap, Inc.
GWG · Endoscope, Neurological · 118d
Cleared Jun 14, 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 239d
Cleared May 04, 1994
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K932202 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 363d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 470d
Cleared Feb 03, 1994
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K932948 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 231d

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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