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

6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
1101–1125 of 6334
Cleared Oct 02, 2020
HAL for Medical Use(Lower Limb type)
K201559 · Cyberdyne, Inc.
PHL · Powered Exoskeleton · 114d
Cleared Sep 30, 2020
Tua Face Fitness / Tua Trend Face
K192077 · Vupiesse S.R.L
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 425d
Cleared Sep 29, 2020
Cadwell Apollo System
K201819 · Cadwell Industries, Inc.
GWQ · Full-montage Standard Electroencephalograph · 90d
Cleared Sep 29, 2020
Cefaly Dual
K201895 · Cefaly Technology
PCC · Stimulator, Nerve, Electrical, Transcutaneous, For Migraine · 83d
Cleared Sep 28, 2020
RIST Radial Access Catheter
K201682 · Rist Neurovascular, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 98d
Cleared Sep 25, 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
K191982 · Shenzhen Kentro Medical Electronics Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 428d
Cleared Sep 25, 2020
Synchro SELECT Guidewire
K202522 · Stryker Neurovascular
MOF · Guide, Wire, Catheter, Neurovasculature · 24d
Cleared Sep 23, 2020
Nerve and Muscle Stimulator
K193276 · Shenzhen Xft Medical Limited
GZI · Stimulator, Neuromuscular, External Functional · 302d
Cleared Sep 18, 2020
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702 · Synthes USA Products, LLC
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 357d
Cleared Sep 14, 2020
VersaWrap Nerve Protector
K201631 · Alafair Biosciences, Inc.
JXI · Cuff, Nerve · 90d
Cleared Sep 14, 2020
Marathon Flow Directed Micro Catheter
K202318 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
KRA · Catheter, Continuous Flush · 28d
Cleared Sep 09, 2020
Keeogo Dermoskeleton System
K201539 · B-Temia, Inc.
PHL · Powered Exoskeleton · 92d
Cleared Sep 06, 2020
EyeBOX
K201841 · Oculogica, Inc.
QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid · 66d
Cleared Sep 04, 2020
MSLS6QF TENS/PMS Device
K193655 · Self Doctor Care, LLC
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 249d
Cleared Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182 · Imperative Care, Inc.
NRY · Catheter, Thrombus Retriever · 29d
Cleared Aug 31, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K201052 · KLS-Martin L.P.
PPT · Cranial Surgical Planning And Instrument Guides · 132d
Cleared Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
K202251 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 21d
Cleared Aug 28, 2020
FitRelief TENS&EMS Wireless Device
K191938 · Heat IN A Click, LLC
NGX · Stimulator, Muscle, Powered, For Muscle Conditioning · 406d
Cleared Aug 26, 2020
MindsEye Expandable Port
K202072 · Minnetronix Neuro, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 30d
Cleared Aug 21, 2020
Brainsway Deep TMS System
K200957 · Brainsway , Ltd.
QMD · Transcranial Magnetic Stimulation System For Smoking Cessation · 134d
Cleared Aug 21, 2020
NeuroBlate System
K201056 · Monteris Medical, Inc.
GEX · Powered Laser Surgical Instrument · 122d
Cleared Aug 14, 2020
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
K200848 · Micron Medical Corporation
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 136d
Cleared Aug 14, 2020
Route 92 Medical 088 Access System
K201518 · Route 92 Medical
QJP · Catheter, Percutaneous, Neurovasculature · 67d
Cleared Aug 13, 2020
StimaWELL 120MTRS
K181645 · Pierenkemper GmbH
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 783d
Cleared Aug 12, 2020
Tyece OTC TENS Model
K200838 · Tyece Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 134d

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All categories 6334 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 605 GXY Electrode, Cutaneous 438 HAW Neurological Stereotaxic Instrument 417 JXG Shunt, Central Nervous System And Components 260 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 218 GWQ Full-montage Standard Electroencephalograph 189 HCG Device, Neurovascular Embolization 187 HCC Device, Biofeedback 172 GWF Stimulator, Electrical, Evoked Response 140 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 133 NRY Catheter, Thrombus Retriever 117 GWM Device, Monitoring, Intracranial Pressure 105 QJP Catheter, Percutaneous, Neurovasculature 102 GWG Endoscope, Neurological 94 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 81