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
6269
Total
6214
Cleared
155d
Avg (2y)
1976
Since
2766 Neurology devices
Cleared
May 23, 2023
Ceribell Status Epilepticus Monitor
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
182d
Cleared
May 22, 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
May 22, 2023
TracStar LDP Large Distal Platform
QJP
Catheter, Percutaneous, Neurovasculature
27d
Cleared
May 18, 2023
Spencer Probe Depth Electrodes
GZL
Electrode, Depth
206d
Cleared
May 18, 2023
Anchor Bolts as Accessories to Depth Electrodes
GZL
Electrode, Depth
206d
Cleared
May 16, 2023
SAVI Dual (TM) Migraine Therapy
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
95d
Cleared
May 13, 2023
HEATING TENS/EMS, FT-810R
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
197d
Cleared
May 12, 2023
Waypoint GPS
QWP
Optical Neurosurgical Nerve Locator
298d
Cleared
May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
230d
Not Cleared
May 09, 2023
Stanza
QWI
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
169d
Cleared
May 08, 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
175d
Cleared
May 04, 2023
Hubly Electric Drill (H100)
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
59d
Cleared
Apr 27, 2023
Cumulus Functional Neurophysiology Platform
GWQ
Full-montage Standard Electroencephalograph
296d
Cleared
Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
30d
Cleared
Apr 25, 2023
Wallaby 017 Micro Catheter
KRA
Catheter, Continuous Flush
203d
Cleared
Apr 24, 2023
SmartGUIDE deflectable hydrophilic guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
230d
Cleared
Apr 20, 2023
STARband 3D
MVA
Orthosis, Cranial
182d
Cleared
Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
HAW
Neurological Stereotaxic Instrument
145d
Cleared
Apr 18, 2023
SENSOSEEG Depth Electrodes
GZL
Electrode, Depth
567d
Cleared
Apr 17, 2023
Localite TMS Navigator TS
HAW
Neurological Stereotaxic Instrument
138d
Cleared
Apr 17, 2023
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
NRY
Catheter, Thrombus Retriever
59d
Not Cleared
Apr 17, 2023
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
QWD
Stimulator, Nerve, For Restless Legs Syndrome
208d
Cleared
Apr 11, 2023
Neuspera Nuity System
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
341d
Cleared
Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
NRY
Catheter, Thrombus Retriever
139d
Cleared
Apr 10, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
NRY
Catheter, Thrombus Retriever
28d
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