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
Cleared
Jul 24, 1991
OPTYX
JXG
Shunt, Central Nervous System And Components
271d
Cleared
Apr 24, 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
JXG
Shunt, Central Nervous System And Components
55d
Cleared
Feb 14, 1991
MEDTRONIC (R) MODEL 3625 SCREENER
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
183d
Cleared
Feb 11, 1991
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
26d
Cleared
Feb 01, 1991
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
60d
Cleared
Jan 30, 1991
MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
126d
Cleared
Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
JXG
Shunt, Central Nervous System And Components
129d
Cleared
Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
GWM
Device, Monitoring, Intracranial Pressure
592d
Cleared
Apr 30, 1990
MODEL 3586 RESUME LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
476d
Cleared
Nov 27, 1989
TENZCARE ELECTRODE 6862
GXY
Electrode, Cutaneous
189d
Cleared
Oct 31, 1989
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
GYK
Instrument, Shunt System Implantation
27d
Cleared
Oct 19, 1989
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
GZT
Retractor, Self-retaining, For Neurosurgery
48d
Cleared
Oct 12, 1989
TENZCARE STIMULATOR 6890
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
198d
Cleared
Aug 07, 1989
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
110d
Cleared
Aug 07, 1989
THE PUDENZ IN LINE VALVE
JXG
Shunt, Central Nervous System And Components
60d
Cleared
Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
JXG
Shunt, Central Nervous System And Components
100d
Cleared
Jan 17, 1989
MODEL 3587A RESUME EPIDURAL LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
53d
Cleared
Jan 17, 1989
MODEL 3487A PISCES EPIDURAL LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
43d
Cleared
Nov 30, 1988
XTREL, MODEL NUMBER 3425
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
85d
Cleared
Jul 18, 1988
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
GXY
Electrode, Cutaneous
84d
Cleared
May 31, 1988
RANEY CLIPS
HBO
Clip, Scalp
68d
Cleared
May 25, 1988
MODEL 3487A PISCES EPIDURAL LEAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
47d
Cleared
Jan 28, 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
GXY
Electrode, Cutaneous
35d
Cleared
Oct 26, 1987
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
JXH
Methyl Methacrylate For Aneurysmorrhaphy
46d
Cleared
Oct 26, 1987
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
GXP
Methyl Methacrylate For Cranioplasty
45d
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