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
1755 Neurology devices
1526–1550 of 1755
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 41d
Cleared May 05, 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 728d
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc.
HCH · Clip, Aneurysm · 84d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 14d
Cleared Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 192d
Cleared Oct 21, 2002
CRANIOCUT
K022942 · Aesculap, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 46d
Cleared Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 136d
Cleared Aug 22, 2002
CONTOUR SE MICROSPHERES
K022427 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 28d
Cleared Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 24d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408 · Synthes (Usa)
GXR · Cover, Burr Hole · 87d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · Aesculap, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 86d
Cleared Jun 14, 2002
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc.
HAW · Neurological Stereotaxic Instrument · 182d
Cleared Apr 05, 2002
MIETHKE SHUNT SYSTEM
K020728 · Aesculap, Inc.
HCA · Catheter, Ventricular · 30d
Cleared Apr 04, 2002
ORTHOPILOT 2
K013569 · Aesculap, Inc.
HAW · Neurological Stereotaxic Instrument · 157d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · Aesculap, Inc.
GWG · Endoscope, Neurological · 90d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 330d
Cleared Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 161d
Cleared Feb 07, 2002
FAST SET PUTTY
K012589 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 181d
Cleared Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 134d
Cleared Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 181d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 204d
Cleared Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
K011584 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 30d
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · Aesculap, Inc.
HBC · Motor, Drill, Electric · 90d
Cleared Jan 29, 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc.
HCH · Clip, Aneurysm · 75d

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All categories 1755 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 HAW Neurological Stereotaxic Instrument 93 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 JXG Shunt, Central Nervous System And Components 73 NRY Catheter, Thrombus Retriever 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GWG Endoscope, Neurological 39 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27