Neurology

Page 1 of 2

Code	Device name	Class	21 CFR	510(k) (3y)
GWE	Stimulator, Photic, Evoked Response	Class 2	21 CFR 882.1890	49
GWF	Stimulator, Electrical, Evoked Response	Class 2	21 CFR 882.1870	140
GWG	Endoscope, Neurological	Class 2	21 CFR 882.1480	93
GWI	Discriminator, Two-Point	Class 1	21 CFR 882.1200	2
GWJ	Stimulator, Auditory, Evoked Response	Class 2	21 CFR 882.1900	76
GWK	Conditioner, Signal, Physiological	Class 2	21 CFR 882.1845	23
GWL	Amplifier, Physiological Signal	Class 2	21 CFR 882.1835	53
GWM	Device, Monitoring, Intracranial Pressure	Class 2	21 CFR 882.1620	105
GWN	Nystagmograph	Class 2	21 CFR 882.1460	60
GWO	Plate, Cranioplasty, Preformed, Alterable	Class 2	21 CFR 882.5320	43
GWQ	Full-Montage Standard Electroencephalograph	Class 2	21 CFR 882.1400	189
GWR	Generator, Electroencephalograph Test Signal	Class 1	21 CFR 882.1430
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Class 1	21 CFR 882.1420	15
GWW	Ataxiagraph	Class 1	21 CFR 882.1030
GWX	Fork, Tuning	Class 1	21 CFR 882.1525	4
GWY	Pinwheel	Class 1	21 CFR 882.1750	5
GWZ	Percussor	Class 1	21 CFR 882.1700	11
GXB	Esthesiometer	Class 1	21 CFR 882.1500	7
GXC	Device, Electroconvulsive Therapy	Class 3	21 CFR 882.5940
GXD	Generator, Lesion, Radiofrequency	Class 2	21 CFR 882.4400	37
GXE	Leukotome	Class 1	21 CFR 882.4600	1
GXH	Device, Surgical, Cryogenic	Class 2	21 CFR 882.4250	23
GXI	Probe, Radiofrequency Lesion	Class 2	21 CFR 882.4725	66
GXJ	Punch, Skull	Class 1	21 CFR 882.4750
GXL	Screwdriver, Skullplate	Class 1	21 CFR 882.4900
GXM	Anvil, Skull Plate	Class 1	21 CFR 882.4030
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Class 2	21 CFR 882.5330	57
GXO	Strip, Craniosynostosis, Preformed	Class 2	21 CFR 882.5900	2
GXP	Methyl Methacrylate For Cranioplasty	Class 2	21 CFR 882.5300	45
GXQ	Dura Substitute	Class 2	21 CFR 882.5910	43
GXR	Cover, Burr Hole	Class 2	21 CFR 882.5250	29
GXS	Monitor, Alpha	Class 2	21 CFR 882.1610
GXT	Monitor, Lesion Temperature	Class 2	21 CFR 882.5500
GXW	Echoencephalograph	Class 2	21 CFR 882.1240	7
GXX	Block, Test, Ultrasonic Scanner Calibration	Class 1	21 CFR 882.1925	3
GXY	Electrode, Cutaneous	Class 2	21 CFR 882.1320	440
GXZ	Electrode, Needle	Class 2	21 CFR 882.1350	53
GYA	Tester, Electrode/Lead, Electroencephalograph	Class 1	21 CFR 882.1410	5
GYB	Media, Electroconductive	Class 2	21 CFR 882.1275	69
GYC	Electrode, Cortical	Class 2	21 CFR 882.1310	32
GYD	Transducer, Tremor	Class 2	21 CFR 882.1950	15
GYE	Encephalogram Telemetry System	Class 2	21 CFR 882.1855	20
GYK	Instrument, Shunt System Implantation	Class 1	21 CFR 882.4545	13
GYZ	Stimulator, Intracerebral/Subcortical, Implanted	Class 3	21 CFR 882.5840
GZA	Implanted Cerebellar Stimulator	Class 3	21 CFR 882.5820
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Class 2	21 CFR 882.5880	139
GZC	Stimulator, Neuromuscular, Implanted	Class 3	21 CFR 882.5860
GZD	Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation	Class 3	21 CFR 882.5850
GZE	Implanted Diaphragmatic/Phrenic Nerve Stimulator	Class 3	21 CFR 882.5830
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Class 2	21 CFR 882.5870	25
GZI	Stimulator, Neuromuscular, External Functional	Class 2	21 CFR 882.5810	61
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Class 2	21 CFR 882.5890	606
GZK	Electrode, Nasopharyngeal	Class 2	21 CFR 882.1340	2
GZL	Electrode, Depth	Class 2	21 CFR 882.1330	58
GZM	Analyzer, Rigidity	Class 2	21 CFR 882.1020
GZN	Rheoencephalograph	Class 3	21 CFR 882.1825
GZO	Device, Galvanic Skin Response Measurement	Class 2	21 CFR 882.1540	26
GZP	Stimulator, Mechanical, Evoked Response	Class 2	21 CFR 882.1880	2
GZQ	Instrument, Dowel Cutting	Class 2	21 CFR 882.4275	1
GZT	Retractor, Self-Retaining, For Neurosurgery	Class 2	21 CFR 882.4800	43
GZX	Instrument, Microsurgical	Class 1	21 CFR 882.4525	13
HAD	Rongeur, Powered	Class 2	21 CFR 882.4845	3
HAE	Rongeur, Manual	Class 2	21 CFR 882.4840	36
HAO	Instrument, Surgical, Non-Powered	Class 1	21 CFR 882.4535	34
HAS	Needle, Neurosurgical Suture	Class 1	21 CFR 882.4650
HAW	Neurological Stereotaxic Instrument	Class 2	21 CFR 882.4560	424
HAX	Tong, Skull For Traction	Class 2	21 CFR 882.5960	20
HBA	Neurosurgical Paddie	Class 2	21 CFR 882.4700	24
HBB	Motor, Drill, Pneumatic	Class 2	21 CFR 882.4370	27
HBC	Motor, Drill, Electric	Class 2	21 CFR 882.4360	26
HBD	Handpiece (Brace), Drill	Class 1	21 CFR 882.4325
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class 2	21 CFR 882.4310	65
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Class 2	21 CFR 882.4305	18
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Class 2	21 CFR 882.4300	17
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Class 2	21 CFR 882.4460	50
HBM	Headrest, Neurosurgical	Class 1	21 CFR 882.4440	3
HBN	Chair, Neurosurgical	Class 1	21 CFR 882.4125	4
HBO	Clip, Scalp	Class 2	21 CFR 882.4150	11
HBP	Clip, Implanted Malleable	Class 2	21 CFR 882.5225
HBQ	Instrument, Clip Removal	Class 1	21 CFR 882.4200
HBR	Rack, Clip	Class 1	21 CFR 882.4215	1
HBS	Instrument, Clip Forming/Cutting	Class 1	21 CFR 882.4190
HBW	Fastener, Plate, Cranioplasty	Class 2	21 CFR 882.5360	7
HBX	Instrument, Cranioplasty Material Forming	Class 1	21 CFR 882.4500
HBZ	Catheter, Intravascular Occluding	Class 3	21 CFR 882.5150
HCA	Catheter, Ventricular	Class 2	21 CFR 882.4100	10
HCB	Device, Aversive Conditioning	Class 2	21 CFR 882.5235	6
HCC	Device, Biofeedback	Class 2	21 CFR 882.5050	172
HCD	Cannula, Ventricular	Class 1	21 CFR 882.4060	3
HCE	Clamp, Carotid Artery	Class 2	21 CFR 882.5175	2
HCG	Device, Neurovascular Embolization	Class 2	21 CFR 882.5950	187
HCH	Clip, Aneurysm	Class 2	21 CFR 882.5200	36
HCI	Applier, Aneurysm Clip	Class 2	21 CFR 882.4175	14
HCJ	Device, Skin Potential Measurement	Class 2	21 CFR 882.1560	2
HCS	Device, Temperature Measurement, Direct Contact, Powered	Class 2	21 CFR 882.1570	8
JXE	Device, Nerve Conduction Velocity Measurement	Class 2	21 CFR 882.1550	27
JXF	Plethysmograph, Ocular	Class 3	21 CFR 882.1790
JXG	Shunt, Central Nervous System And Components	Class 2	21 CFR 882.5550	259
JXH	Methyl Methacrylate For Aneurysmorrhaphy	Class 2	21 CFR 882.5030	3
JXI	Cuff, Nerve	Class 2	21 CFR 882.5275	40
JXK	Cranial Electrotherapy Stimulator To Treat Depression	Class 3	21 CFR 882.5800
JXL	Block, Bite	Class 2	21 CFR 882.5070	28
LEL	Device, Sleep Assessment	Class 2	21 CFR 882.5050	19
LEM	Human Lyophilized Dura Mater	Class 2	21 CFR 882.5975	2
LHG	Electrode, Spinal Epidural	Class 2	21 CFR 882.5880	1
LIH	Interferential Current Therapy	Class 2	21 CFR 882.5890	73
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Class 2	21 CFR 882.5550	8
LLN	Device, Vibration Threshold Measurement	Class 1	21 CFR 882.1200	13
LQW	Test, Temperature Discrimination	Class 1	21 CFR 882.1200	3
MVA	Orthosis, Cranial	Class 2	21 CFR 882.5970	43
MYU	Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty	Class 2	21 CFR 882.5300	6
MZQ	Balloon, Detachable, For Neurovascular Occlusion	Class 2	21 CFR 882.5950	2
NCG	Neuropsychiatric Interpretative Electroencephalograph Assessment Aid	Class 2	21 CFR 882.1440	3
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Class 2	21 CFR 882.5890	79
NHC	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)	Class 2	21 CFR 882.4100	3
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Class 2	21 CFR 882.5890	13
NLN	Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed	Class 2	21 CFR 882.4310	1
NLO	Drills, Burrs, Trephines And Accessories (Manual), Reprocessed	Class 2	21 CFR 882.4300
NLP	Drills, Burrs, Trephines, And Accessories (Powered Compound), Reproces	Class 2	21 CFR 882.4305
NMN	Instrument, Clip, Forming/Cutting, Reprocessed	Class 1	21 CFR 882.4190
NTU	Evoked Potential Stimulator, Thermal	Class 2	21 CFR 882.1870	3
NUF	Catheter, Neurovasculature, Occluding Balloon	Class 3	21 CFR 882.5150
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Class 2	21 CFR 882.5890	229
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Class 2	21 CFR 882.5890	8
NYW	Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, Fo	Class 2	21 CFR 882.5890
NYX	Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesth	Class 2	21 CFR 882.5890
OAN	Orthosis, Cranial, Laser Scan	Class 2	21 CFR 882.5970	23
OBP	Transcranial Magnetic Stimulator	Class 2	21 CFR 882.5805	68
OBV	Eating Disorder Conditioning Tool	Class 2	21 CFR 882.5060	1
OCF	Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthrit	Class 2	21 CFR 882.5890	1
OEW	Tracking, Soft Tissue, Intraoperative	Class 2	21 CFR 882.4560	4
OJG	Neurological Tray	Class 1	21 CFR 882.4525
OJP	Orthopedic Computer Controlled Surgical System	Class 2	21 CFR 882.4560	4
OKP	Transcranial Magnetic Stimulator For The Treatment Of Migraine Headach	Class 2	21 CFR 882.5808	6
OLO	Orthopedic Stereotaxic Instrument	Class 2	21 CFR 882.4560	440
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Class 2	21 CFR 882.1400	56
OLU	Normalizing Quantitative Electroencephalograph Software	Class 2	21 CFR 882.1400	13
OLV	Standard Polysomnograph With Electroencephalograph	Class 2	21 CFR 882.1400	65
OLW	Index-Generating Electroencephalograph Software	Class 2	21 CFR 882.1400	40
OLX	Source Localization Software For Electroencephalograph Or Magnetoencep	Class 2	21 CFR 882.1400	25
OLY	Magnetoencephalograph	Class 2	21 CFR 882.1400	6
OLZ	Automatic Event Detection Software For Polysomnograph With Electroence	Class 2	21 CFR 882.1400	37
OMA	Amplitude-Integrated Electroencephalograph	Class 2	21 CFR 882.1400	16
OMB	Automatic Event Detection Software For Full-Montage Electroencephalogr	Class 2	21 CFR 882.1400	42
OMC	Reduced- Montage Standard Electroencephalograph	Class 2	21 CFR 882.1400	29
ONA	Computer Assisted Hair Harvesting System	Class 2	21 CFR 882.4560	4
ONN	Intraoperative Orthopedic Joint Assessment Aid	Class 2	21 CFR 882.4560	18
ORR	Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri	Class 2	21 CFR 882.4560	4
ORT	Burst Suppression Detection Software For Electroencephalograph	Class 2	21 CFR 882.1400	1
OSE	Patient Specific Manual Navigation System	Class 2	21 CFR 882.4560
OSF	Patient Specific Manual Orthopedic Stereotaxic System	Class 2	21 CFR 882.4560	3
OSG	Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch	Class 2	21 CFR 882.5894	2
PAV	Catheter, Neuro-Vasculature, Occluding Balloon	Class F	21 CFR 882.5150
PBJ	Cranial Distraction System	Class 2	21 CFR 882.5330	6
PCB	External Cerebrospinal Fluid (Csf) Diversion	Class 2	21 CFR 882.5560	2
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Class 2	21 CFR 882.5891	18
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Class 2	21 CFR 882.4560	37
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment	Class 2	21 CFR 882.1450	9
PIY	Stainless Steel Instrument, Shunt System Implantation	Class 1	21 CFR 882.4545
PJM	Filler, Bone Void, Alterable Compound For Cranioplasty	Class 2	21 CFR 882.5320
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Class 2	21 CFR 882.5330	2
PKQ	Computerized Cognitive Assessment Aid	Class 2	21 CFR 882.1470	3
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Class 2	21 CFR 882.5892	9
PLU	Thermal System For Insomnia	Class 2	21 CFR 882.5700	1
PNA	Evoked Photon Image Capture Device	Class 1	21 CFR 882.1561	1
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke	Class 2	21 CFR 882.5600	18
POM	Computerized Cognitive Assessment Aid For Concussion	Class 2	21 CFR 882.1471	8
POP	Cranial Motion Measurement Device	Class 2	21 CFR 882.1630	2
POS	Physiological Signal Based Seizure Monitoring System	Class 2	21 CFR 882.1580	10
PPT	Cranial Surgical Planning And Instrument Guides	Class 2	21 CFR 882.4310	4
PSP	Intracranial Pressure & Temperature Monitoring Kit	Class 2	21 CFR 882.1620
PTB	Ataxiagraph With Interpretive Software	Class 1	21 CFR 882.1030
PTY	Computerized Cognitive Assessment Aid, Exempt	Class 2	21 CFR 882.1470
PUU	Temporary Coil Embolization Assist Device	Class 2	21 CFR 882.5955	1
PVL	Endoscopic Shunt Placement Kit	Class 2	21 CFR 882.5550
PVM	Endoscopic Ventricular Catheter Placement Kit	Class 2	21 CFR 882.4100
PVO	Lumbar Drainage Catheter Kit	Class 2	21 CFR 882.5550
PVP	Neurological Test Kit	Class 1	21 CFR 882.1750
PWE	Computerized Behavioral Therapy Device For Substance Use Disorders	Class 2	21 CFR 882.5801	2
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal	Class 2	21 CFR 882.5896	8
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Class 2	21 CFR 882.5892
QAR	Thermal Vestibular Stimulator For Headache	Class 2	21 CFR 882.5893	1
QBC	External Upper Limb Tremor Stimulator	Class 2	21 CFR 882.5897	9
QCF	Electrical Tongue Stimulator To Treat Motor Deficits	Class 2	21 CFR 882.5889	2
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Diso	Class 2	21 CFR 882.5802	9
QEA	Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid	Class 2	21 CFR 882.1455	7
QEO	Light Attenuation Lenses For Migraine-Associated Light Sensitivity	Class 1	21 CFR 882.5811	1
QFD	Tens For Sinus Pain	Class 2	21 CFR 882.5890
QFF	Electromechanical Arm For A Transcranial Magnetic Stimulation System	Class 2	21 CFR 882.5805	2
QFX	Diagnostic Neurosurgical Microscope Filter	Class 2	21 CFR 882.4950	5
QGH	Electroconvulsive Therapy Device For Catatonia, Major Depressive Disor	Class 2	21 CFR 882.5940	9
QGL	Transcutaneous Nerve Stimulator For Adhd	Class 2	21 CFR 882.5898	5
QGT	Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Mig	Class 2	21 CFR 882.5899	7
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Class 2	21 CFR 882.5800	19
QLV	Field Generator Positioning Device	Class 1	21 CFR 882.4565
QMD	Transcranial Magnetic Stimulation System For Smoking Cessation	Class 2	21 CFR 882.5802	2
QMZ	Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Con	Class 2	21 CFR 882.5705	1
QNX	External Compression Device For Internal Jugular Vein Compression	Class 2	21 CFR 890.3050	1
QOL	Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser	Class 2	21 CFR 890.5420	1
QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid	Class 2	21 CFR 882.1491	6