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

1501–1525 of 1755

Cleared Oct 21, 2005

DEPUY CAS HIP INSTRUMENTATION

K052178 · DePuy Orthopaedics, Inc.

HAW · Neurological Stereotaxic Instrument · 72d

Cleared Apr 27, 2005

AESCULAP ORTHOPILOT 2 THA V 2.0

K050752 · Aesculap, Inc.

HAW · Neurological Stereotaxic Instrument · 35d

Cleared Apr 15, 2005

MATRIX STRETCH RESISTANT (SR) COILS

K050700 · Boston Scientific Corp

HCG · Device, Neurovascular Embolization · 28d

Cleared Mar 04, 2005

DEPUY CAS KNEE INSTRUMENTATION

K043223 · DePuy Orthopaedics, Inc.

HAW · Neurological Stereotaxic Instrument · 102d

Cleared Dec 21, 2004

MIMIX MP BONE VOID FILLER

K043280 · Biomet, Inc.

GXP · Methyl Methacrylate For Cranioplasty · 25d

Cleared Dec 09, 2004

AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)

K043041 · Aesculap, Inc.

HCH · Clip, Aneurysm · 35d

Cleared Oct 19, 2004

GDC-10 360 DEGREE COIL SR

K042539 · Boston Scientific Corp

HCG · Device, Neurovascular Embolization · 29d

Cleared Sep 10, 2004

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

K033341 · Smith & Nephew, Inc.

HAW · Neurological Stereotaxic Instrument · 329d

Cleared Sep 08, 2004

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

K041611 · Synthes (Usa)

GXR · Cover, Burr Hole · 85d

Cleared Aug 12, 2004

POLYGRAM NET BIOFEEDBACK APPLICATION

K041244 · Medtronic Vascular

HCC · Device, Biofeedback · 93d

Cleared Jul 08, 2004

ACUMEN SURGICAL NAVIGATION SYSTEM

K031454 · Biomet, Inc.

HAW · Neurological Stereotaxic Instrument · 428d

Cleared Jul 08, 2004

SYNTHES (USA) CHRONOS

K041350 · Synthes (Usa)

GXP · Methyl Methacrylate For Cranioplasty · 49d

Cleared Jun 21, 2004

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

K033868 · Synthes (Usa)

GXN · Plate, Cranioplasty, Preformed, Non-alterable · 192d

Cleared Mar 31, 2004

AESCULAP ABSORBABLE CRANIOFIX

K040080 · Aesculap, Inc.

GXR · Cover, Burr Hole · 76d

Cleared Mar 25, 2004

POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS

K040568 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 21d

Cleared Mar 16, 2004

SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

K034012 · Smith & Nephew, Inc.

GXI · Probe, Radiofrequency Lesion · 83d

Cleared Feb 18, 2004

ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS

K033223 · Zimmer, Inc.

HAW · Neurological Stereotaxic Instrument · 135d

Cleared Feb 12, 2004

ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS

K033011 · Zimmer, Inc.

HAW · Neurological Stereotaxic Instrument · 139d

Cleared Sep 23, 2003

CONTOUR SE MICROSPHERES (SYRINGE)

K032707 · Boston Scientific Corp

HCG · Device, Neurovascular Embolization · 21d

Cleared Sep 22, 2003

K031280 · Biomet, Inc.

JDX · Instrument, Surgical, Sonic And Accessory/attachment · 153d

Cleared Sep 16, 2003

MODIFICATION TO CONTOUR SE MICROSPHERES

K032542 · Boston Scientific Corp

HCG · Device, Neurovascular Embolization · 29d

Cleared Sep 15, 2003

ACUMEN SURGICAL NAVIGATION SYSTEM

K031337 · Biomet, Inc.

HAW · Neurological Stereotaxic Instrument · 140d

Cleared Sep 11, 2003

RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR

K032561 · Medtronic Vascular

GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 22d

Cleared Aug 20, 2003

AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP

K032198 · Aesculap, Inc.

HCH · Clip, Aneurysm · 33d

Cleared Aug 08, 2003

SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

K031654 · Synthes (Usa)

GXR · Cover, Burr Hole · 72d

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