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
1476–1500 of 1755
Cleared Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 122d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
K092666 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 30d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 101d
Cleared Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 79d
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 79d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 109d
Cleared May 09, 2008
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 256d
Cleared Dec 18, 2007
SYNTHES (USA) 2.0MM TITANIUM T-PLATE
K072758 · Synthes (Usa)
GWO · Plate, Cranioplasty, Preformed, Alterable · 81d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 72d
Cleared Jul 12, 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 27d
Cleared Jul 02, 2007
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc.
HAW · Neurological Stereotaxic Instrument · 52d
Cleared May 23, 2007
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc.
HAW · Neurological Stereotaxic Instrument · 30d
Cleared Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 184d
Cleared Nov 21, 2006
AESCULAP PNEUMATIC KERRISON
K062413 · Aesculap, Inc.
HAD · Rongeur, Powered · 96d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 28d
Cleared Nov 08, 2006
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
K062228 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 98d
Cleared Sep 15, 2006
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc.
HBA · Neurosurgical Paddie · 29d
Cleared Aug 16, 2006
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K062041 · Medtronic, Inc.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 28d
Cleared Aug 04, 2006
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K053348 · Howmedica Osteonics Corp.
HAW · Neurological Stereotaxic Instrument · 245d
Cleared Jul 31, 2006
BRIGIT SURGICAL DEVICE
K060556 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 151d
Cleared Apr 13, 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 51d
Cleared Apr 13, 2006
NORIAN CRS BONE CEMENT
K060445 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 51d
Cleared Jan 18, 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc.
HBC · Motor, Drill, Electric · 30d
Cleared Dec 28, 2005
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K052425 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 117d
Cleared Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa)
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 28d

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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 NRY Catheter, Thrombus Retriever 73 JXG Shunt, Central Nervous System And Components 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