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
1707 Neurology devices
726–750 of 1707
Cleared Jun 24, 2022
Sugita AVM Microclip Applier
K221524 · Mizuho America, Inc.
HCI · Applier, Aneurysm Clip · 29d
Cleared Jun 20, 2022
NeuroLine Disposable Cranial Perforator with Hudson end
K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 264d
Cleared Jun 16, 2022
Seer Home
K212788 · Seer Medical Pty, Ltd.
GWQ · Full-montage Standard Electroencephalograph · 288d
Cleared Jun 15, 2022
EEG-acp
K212325 · Somnomedics GmbH
GYB · Media, Electroconductive · 324d
Cleared Jun 11, 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · Hivox Biotek, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 29d
Cleared Jun 10, 2022
Armory Motion
K213097 · Pain Management Technologies, Inc.
ILO · Pack, Hot Or Cold, Water Circulating · 259d
Cleared Jun 10, 2022
Rune Labs Tremor Transducer System
K213519 · Rune Labs, Inc.
GYD · Transducer, Tremor · 219d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 58d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376 · Boston Scientific Neuromodulation
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 29d
Cleared Jun 09, 2022
MyCRO Band
K213587 · Otto Bock Healthcare LP
MVA · Orthosis, Cranial · 209d
Cleared Jun 09, 2022
EksoNR
K220988 · Ekso Bionics, Inc.
PHL · Powered Exoskeleton · 66d
Cleared Jun 08, 2022
EarliPoint System
K213882 · Earlitec Diagnostics, Inc.
QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid · 177d
Cleared Jun 06, 2022
Drug Relief v1
K221231 · Dyansys, Inc.
PZR · Percutaneous Nerve Stimulator For Opioid Withdrawal · 38d
Cleared Jun 03, 2022
KLS Martin Neuro Rongeurs
K210741 · KLS-Martin L.P.
HAE · Rongeur, Manual · 448d
Cleared Jun 02, 2022
Minjie Catheter System
K212288 · Kai Medtech, LLC
QJP · Catheter, Percutaneous, Neurovasculature · 316d
Cleared Jun 02, 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
K220008 · Zoll Circulation, Inc.
NCX · System, Hypothermia, Intravenous, Cooling · 149d
Cleared Jun 01, 2022
AneuGuide
K213838 · ArteryFlow Technology Co., Ltd.
PZO · Software For Visualization Of Vascular Anatomy And Intravascular Devices · 174d
Cleared May 31, 2022
Distal Access Catheter
K213065 · Guangzhou Easycess Medical Co.,Ltd
QJP · Catheter, Percutaneous, Neurovasculature · 250d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · Penumbra, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 262d
Cleared May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578 · Bozhou Rongjian Medical Appliance Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 86d
Cleared May 20, 2022
iovera System
K220656 · Pacira Biosciences, Inc.
GXH · Device, Surgical, Cryogenic · 74d
Cleared May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
K220485 · The Anspach Effort, Inc.
HBC · Motor, Drill, Electric · 91d
Not Cleared May 18, 2022
Quell-FM
DEN210046 · Neurometrix, Inc.
QSQ · Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms · 225d
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807 · Imperative Care, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 60d
Cleared May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
K210615 · Thompson Surgical Instruments, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 438d

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All categories 1707 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 HAW Neurological Stereotaxic Instrument 88 NRY Catheter, Thrombus Retriever 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 JXG Shunt, Central Nervous System And Components 63 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 DQY Catheter, Percutaneous 36 GWG Endoscope, Neurological 33 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27