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
Cleared
Dec 01, 2017
MR Conditional Cup Electrode, MR Conditional Webb Electrode
GXY
Electrode, Cutaneous
105d
Cleared
Nov 30, 2017
Foot Drop System (Model XFT-2001D)
GZI
Stimulator, Neuromuscular, External Functional
427d
Cleared
Nov 30, 2017
ReliefBand 1.5
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
56d
Cleared
Nov 29, 2017
HIVOX OTC Electrical Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
163d
Cleared
Nov 28, 2017
Cefaly Dual
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
62d
Cleared
Nov 27, 2017
Cerafix Dura Substitute
GXQ
Dura Substitute
89d
Cleared
Nov 24, 2017
DIXI Medical Microdeep Depth Electrode
GZL
Electrode, Depth
238d
Cleared
Nov 17, 2017
Dr.MUSIC 3s
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
95d
Not Cleared
Nov 15, 2017
NSS-2 System
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
243d
Cleared
Nov 14, 2017
Smart External Drain (SED) System
JXG
Shunt, Central Nervous System And Components
62d
Cleared
Nov 13, 2017
Stryker Universal Mesh
GWO
Plate, Cranioplasty, Preformed, Alterable
249d
Cleared
Nov 13, 2017
Disposable Snap Electrode
GXY
Electrode, Cutaneous
67d
Cleared
Nov 10, 2017
Nexstim Navigated Brain Therapy (NBT) System 2
OBP
Transcranial Magnetic Stimulator
137d
Cleared
Nov 10, 2017
Aesculap Slim Clip Applier Forceps
HCI
Applier, Aneurysm Clip
29d
Cleared
Nov 09, 2017
Alivio Ventricular Catheter and Flusher System (Alivio System)
JXG
Shunt, Central Nervous System And Components
129d
Cleared
Nov 08, 2017
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
GWM
Device, Monitoring, Intracranial Pressure
37d
Cleared
Nov 03, 2017
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
63d
Cleared
Nov 03, 2017
Comet-PLUS
OLV
Standard Polysomnograph With Electroencephalograph
56d
Cleared
Nov 01, 2017
Mytens Model: BW-TSX
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
210d
Cleared
Oct 25, 2017
Smart Photon Micro-current Device, Model: EP-300
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
397d
Cleared
Oct 23, 2017
BeneLife Premium Facial Treatment Pack, Model: QZ0701A
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
140d
Cleared
Oct 20, 2017
ClearPoint System
ORR
Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
175d
Cleared
Oct 19, 2017
Avail
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
101d
Cleared
Oct 18, 2017
OTC Combo TENS/EMS System
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
30d
Cleared
Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
JXG
Shunt, Central Nervous System And Components
55d
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