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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
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Neurology
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Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
GXW
Echoencephalograph
2
Product Code
GXX
Block, Test, Ultrasonic Scanner Calibration
1
Product Code
GXY
Electrode, Cutaneous
2
Product Code
GXZ
Electrode, Needle
2
Product Code
GYA
Tester, Electrode/Lead, Electroencephalograph
1
Product Code
GXS
Monitor, Alpha
2
Product Code
GWE
Stimulator, Photic, Evoked Response
2
Product Code
GWF
Stimulator, Electrical, Evoked Response
2
Product Code
GWG
Endoscope, Neurological
2
Product Code
K
23
3391
cCeLL - In vivo
2
Cleared 510(K)
K
22
3615
Digital ClarusScope System, Digital NeuroPEN System
2
Cleared 510(K)
K
23
2618
Aurora Surgiscope System
2
Cleared 510(K)
K
23
0125
Neuroblade System
2
Cleared 510(K)
K
23
2159
QEVO System
2
Cleared 510(K)
K
22
2735
HJY VisualNext Endoscopic Vision System
2
Cleared 510(K)
K
21
1202
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
2
Cleared 510(K)
K
21
0251
ClearPath Disposable Introducer
2
Cleared 510(K)
K
20
0925
Clarus Peel-Away Introducer Sheath
2
Cleared 510(K)
K
20
1308
Axonpen, Axonmonitor, Axonbox, Tablet
2
Cleared 510(K)
K
20
1840
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
2
Cleared 510(K)
K
19
1861
Aurora Surgiscope System
2
Cleared 510(K)
K
19
0719
Artemis Eye System
2
Cleared 510(K)
K
18
2211
Aurora Surgiscope System
2
Cleared 510(K)
K
18
1731
MR Compatible Aspiration Kit
2
Cleared 510(K)
K
18
1116
CONVIVO
2
Cleared 510(K)
K
18
0270
Cellvizio 100 Series Systems with Confocal Miniprobes
2
Cleared 510(K)
K
18
0146
KARL STORZ ICG Imaging System
2
Cleared 510(K)
K
17
0667
QEVO System with KINEVO 900
2
Cleared 510(K)
K
17
1332
Artemis Neuro Evacuation Device
2
Cleared 510(K)
K
17
0462
KARL STORZ ShuntScope
2
Cleared 510(K)
K
16
2880
TIPCAM 1S 3D System
2
Cleared 510(K)
K
16
1112
KARL STORZ Flexible Video-Neuro-Endoscope System
2
Cleared 510(K)
K
15
2699
Apollo System
2
Cleared 510(K)
K
14
2315
MINOP Disposable Introducer 26F
2
Cleared 510(K)
K
13
2931
APOLLO SYSTEM
2
Cleared 510(K)
K
13
1434
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
2
Cleared 510(K)
K
08
1102
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
2
Cleared 510(K)
K
07
2410
KSEA CLEARVISION II, MODEL 40334120
2
Cleared 510(K)
K
06
1135
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
2
Cleared 510(K)
K
05
2745
ASSISTO ARM SYSTEMS
2
Cleared 510(K)
K
04
3128
OLYMPUS ENDOARM
2
Cleared 510(K)
K
03
1858
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
2
Cleared 510(K)
K
02
2198
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
2
Cleared 510(K)
K
02
0507
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
2
Cleared 510(K)
K
01
3759
MSS-28CS-301/701 NEEDLESCOPE
2
Cleared 510(K)
K
02
1050
KSEA NEUROENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
01
4149
PAEDISCOPE, MODEL # P010A AND PF011A
2
Cleared 510(K)
K
01
0341
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
2
Cleared 510(K)
K
00
3914
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
2
Cleared 510(K)
K
00
2572
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
2
Cleared 510(K)
K
00
2704
KSEA MINIATURE NEUROENDOSCOPE
2
Cleared 510(K)
K
00
2788
KSEA NEURO-FIBERSCOPE
2
Cleared 510(K)
K
00
2330
NAVIGUS PEEL AWAY INTRODUCER
2
Cleared 510(K)
K
00
1630
KSEA BIPOLAR COAGULATING ELECTRODES
2
Cleared 510(K)
K
99
3568
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
2
Cleared 510(K)
K
99
3539
DCI ENDOSCOPE
2
Cleared 510(K)
K
99
1989
MITAKA POINT SETTER
2
Cleared 510(K)
K
99
1069
KSEA NEURO-FIBERSCOPE
2
Cleared 510(K)
K
99
0333
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
2
Cleared 510(K)
K
98
2819
ENDIUS SPINE ENDOSCOPE
2
Cleared 510(K)
K
98
3365
AESCULAP MINOP SYSTEM
2
Cleared 510(K)
K
98
2837
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
2
Cleared 510(K)
K
97
1340
OLYMPUS NEURO ENDOSCOPE
2
Cleared 510(K)
K
96
3642
INCL II ENDOSCOPE
2
Cleared 510(K)
K
97
0162
NEUROLOGICAL ENDOSCOPE
2
Cleared 510(K)
K
96
4281
AESCULAP ANGLED NEUROENDOSCOPES
2
Cleared 510(K)
K
96
5078
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
2
Cleared 510(K)
K
96
0915
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
2
Cleared 510(K)
K
96
1406
NEUROVIEW SCISSORS
2
Cleared 510(K)
K
96
1300
ASPIRATION/IRRIGATION CATHETER
2
Cleared 510(K)
K
96
1173
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
2
Cleared 510(K)
K
96
0792
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
2
Cleared 510(K)
K
95
4938
DISPOSABLE NEUROVIEW OPERATING SHEATH
2
Cleared 510(K)
K
95
4394
AESCULAP VENTRICULOSCOPE SYSTEM
2
Cleared 510(K)
K
95
5351
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
2
Cleared 510(K)
K
95
5598
CLARUS SPINEPEN MODEL 2126
2
Cleared 510(K)
K
95
4899
RIGID NEUROVIEW ENDOSCOPE
2
Cleared 510(K)
K
95
3554
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
95
3685
INSTRUMENT SCOPE
2
Cleared 510(K)
K
95
3173
NONPOWERED NEUROSURGICAL INSTRUMENT
2
Cleared 510(K)
K
94
5633
NEURO CHANNEL ENDOSCOPE MODEL 2232
2
Cleared 510(K)
K
95
0154
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
94
5296
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
2
Cleared 510(K)
K
94
0273
NOBLES-LAI VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
93
4154
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
2
Cleared 510(K)
K
94
5572
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
2
Cleared 510(K)
K
94
2413
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR
2
Cleared 510(K)
K
94
2249
CLARUS NEUROPEN MODEL 2120
2
Cleared 510(K)
K
94
2955
DISPOSABLE BIPOLAR ELECTRODE
2
Cleared 510(K)
K
94
1239
AESCULAP NEUROENDOSCOPE
2
Cleared 510(K)
K
94
0096
PS MEDICAL CATHETER PLACEMENT KIT
2
Cleared 510(K)
K
93
4196
CODMAN QUICK SHUNT KIT, CAT. #82-6570
2
Cleared 510(K)
K
92
4977
CODMAN LASER NEUROENDOSCOPE
2
Cleared 510(K)
K
93
1973
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
2
Cleared 510(K)
K
93
3244
DISPOSABLE GRASPING FORCEP
2
Cleared 510(K)
K
92
5881
DISPOSABLE BIOPSY FORCEP
2
Cleared 510(K)
K
92
3479
DISPOSABLE NEUROVIEW ENDOSCOPE
2
Cleared 510(K)
K
92
3646
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
2
Cleared 510(K)
GWI
Discriminator, Two-Point
1
Product Code
GWJ
Stimulator, Auditory, Evoked Response
2
Product Code
GWK
Conditioner, Signal, Physiological
2
Product Code
GWL
Amplifier, Physiological Signal
2
Product Code
GWM
Device, Monitoring, Intracranial Pressure
2
Product Code
GWN
Nystagmograph
2
Product Code
GWQ
Full-Montage Standard Electroencephalograph
2
Product Code
GWR
Generator, Electroencephalograph Test Signal
1
Product Code
GWS
Analyzer, Spectrum, Electroencephalogram Signal
1
Product Code
GWW
Ataxiagraph
1
Product Code
GWX
Fork, Tuning
1
Product Code
GWY
Pinwheel
1
Product Code
GWZ
Percussor
1
Product Code
GXB
Esthesiometer
1
Product Code
GYB
Media, Electroconductive
2
Product Code
GYC
Electrode, Cortical
2
Product Code
GYD
Transducer, Tremor
2
Product Code
GYE
Encephalogram Telemetry System
2
Product Code
GZK
Electrode, Nasopharyngeal
2
Product Code
GZL
Electrode, Depth
2
Product Code
GZM
Analyzer, Rigidity
2
Product Code
GZN
Rheoencephalograph
3
Product Code
GZO
Device, Galvanic Skin Response Measurement
2
Product Code
GZP
Stimulator, Mechanical, Evoked Response
2
Product Code
HCJ
Device, Skin Potential Measurement
2
Product Code
HCS
Device, Temperature Measurement, Direct Contact, Powered
2
Product Code
JXE
Device, Nerve Conduction Velocity Measurement
2
Product Code
JXF
Plethysmograph, Ocular
3
Product Code
LLN
Device, Vibration Threshold Measurement
1
Product Code
LQW
Test, Temperature Discrimination
1
Product Code
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
2
Product Code
NTU
Evoked Potential Stimulator, Thermal
2
Product Code
OLT
Non-Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLU
Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLV
Standard Polysomnograph With Electroencephalograph
2
Product Code
OLW
Index-Generating Electroencephalograph Software
2
Product Code
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
2
Product Code
OLY
Magnetoencephalograph
2
Product Code
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
2
Product Code
OMA
Amplitude-Integrated Electroencephalograph
2
Product Code
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
2
Product Code
OMC
Reduced- Montage Standard Electroencephalograph
2
Product Code
ORT
Burst Suppression Detection Software For Electroencephalograph
2
Product Code
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
2
Product Code
PKQ
Computerized Cognitive Assessment Aid
2
Product Code
PNA
Evoked Photon Image Capture Device
1
Product Code
POM
Computerized Cognitive Assessment Aid For Concussion
2
Product Code
POP
Cranial Motion Measurement Device
2
Product Code
POS
Physiological Signal Based Seizure Monitoring System
2
Product Code
PSP
Intracranial Pressure & Temperature Monitoring Kit
2
Product Code
PTB
Ataxiagraph With Interpretive Software
1
Product Code
PTY
Computerized Cognitive Assessment Aid, Exempt
2
Product Code
PVP
Neurological Test Kit
1
Product Code
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
2
Product Code
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
2
Product Code
OPT
Infrared Hematoma Detector
2
Product Code
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
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Review Panel
Orthopedic
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 13 December 2024 at 11:05 pm
NE
/
subpart-b—neurological-diagnostic-devices
/
GWG
/
K934154
View Source
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934154
510(k) Type
Traditional
Applicant
NEURO NAVIGATIONAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/21/1995
Days to Decision
543 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
GXW
Echoencephalograph
GXX
Block, Test, Ultrasonic Scanner Calibration
GXY
Electrode, Cutaneous
GXZ
Electrode, Needle
GYA
Tester, Electrode/Lead, Electroencephalograph
GXS
Monitor, Alpha
GWE
Stimulator, Photic, Evoked Response
GWF
Stimulator, Electrical, Evoked Response
GWG
Endoscope, Neurological
K
23
3391
cCeLL - In vivo
K
22
3615
Digital ClarusScope System, Digital NeuroPEN System
K
23
2618
Aurora Surgiscope System
K
23
0125
Neuroblade System
K
23
2159
QEVO System
K
22
2735
HJY VisualNext Endoscopic Vision System
K
21
1202
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
K
21
0251
ClearPath Disposable Introducer
K
20
0925
Clarus Peel-Away Introducer Sheath
K
20
1308
Axonpen, Axonmonitor, Axonbox, Tablet
K
20
1840
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
K
19
1861
Aurora Surgiscope System
K
19
0719
Artemis Eye System
K
18
2211
Aurora Surgiscope System
K
18
1731
MR Compatible Aspiration Kit
K
18
1116
CONVIVO
K
18
0270
Cellvizio 100 Series Systems with Confocal Miniprobes
K
18
0146
KARL STORZ ICG Imaging System
K
17
0667
QEVO System with KINEVO 900
K
17
1332
Artemis Neuro Evacuation Device
K
17
0462
KARL STORZ ShuntScope
K
16
2880
TIPCAM 1S 3D System
K
16
1112
KARL STORZ Flexible Video-Neuro-Endoscope System
K
15
2699
Apollo System
K
14
2315
MINOP Disposable Introducer 26F
K
13
2931
APOLLO SYSTEM
K
13
1434
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K
08
1102
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
K
07
2410
KSEA CLEARVISION II, MODEL 40334120
K
06
1135
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
K
05
2745
ASSISTO ARM SYSTEMS
K
04
3128
OLYMPUS ENDOARM
K
03
1858
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
K
02
2198
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K
02
0507
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K
01
3759
MSS-28CS-301/701 NEEDLESCOPE
K
02
1050
KSEA NEUROENDOSCOPES AND ACCESSORIES
K
01
4149
PAEDISCOPE, MODEL # P010A AND PF011A
K
01
0341
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
K
00
3914
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
K
00
2572
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
K
00
2704
KSEA MINIATURE NEUROENDOSCOPE
K
00
2788
KSEA NEURO-FIBERSCOPE
K
00
2330
NAVIGUS PEEL AWAY INTRODUCER
K
00
1630
KSEA BIPOLAR COAGULATING ELECTRODES
K
99
3568
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K
99
3539
DCI ENDOSCOPE
K
99
1989
MITAKA POINT SETTER
K
99
1069
KSEA NEURO-FIBERSCOPE
K
99
0333
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
K
98
2819
ENDIUS SPINE ENDOSCOPE
K
98
3365
AESCULAP MINOP SYSTEM
K
98
2837
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K
97
1340
OLYMPUS NEURO ENDOSCOPE
K
96
3642
INCL II ENDOSCOPE
K
97
0162
NEUROLOGICAL ENDOSCOPE
K
96
4281
AESCULAP ANGLED NEUROENDOSCOPES
K
96
5078
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
K
96
0915
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K
96
1406
NEUROVIEW SCISSORS
K
96
1300
ASPIRATION/IRRIGATION CATHETER
K
96
1173
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
K
96
0792
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
K
95
4938
DISPOSABLE NEUROVIEW OPERATING SHEATH
K
95
4394
AESCULAP VENTRICULOSCOPE SYSTEM
K
95
5351
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K
95
5598
CLARUS SPINEPEN MODEL 2126
K
95
4899
RIGID NEUROVIEW ENDOSCOPE
K
95
3554
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
K
95
3685
INSTRUMENT SCOPE
K
95
3173
NONPOWERED NEUROSURGICAL INSTRUMENT
K
94
5633
NEURO CHANNEL ENDOSCOPE MODEL 2232
K
95
0154
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
K
94
5296
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
K
94
0273
NOBLES-LAI VIDEO IMAGING SYSTEM
K
93
4154
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
K
94
5572
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K
94
2413
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR
K
94
2249
CLARUS NEUROPEN MODEL 2120
K
94
2955
DISPOSABLE BIPOLAR ELECTRODE
K
94
1239
AESCULAP NEUROENDOSCOPE
K
94
0096
PS MEDICAL CATHETER PLACEMENT KIT
K
93
4196
CODMAN QUICK SHUNT KIT, CAT. #82-6570
K
92
4977
CODMAN LASER NEUROENDOSCOPE
K
93
1973
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
K
93
3244
DISPOSABLE GRASPING FORCEP
K
92
5881
DISPOSABLE BIOPSY FORCEP
K
92
3479
DISPOSABLE NEUROVIEW ENDOSCOPE
K
92
3646
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
GWI
Discriminator, Two-Point
GWJ
Stimulator, Auditory, Evoked Response
GWK
Conditioner, Signal, Physiological
GWL
Amplifier, Physiological Signal
GWM
Device, Monitoring, Intracranial Pressure
GWN
Nystagmograph
GWQ
Full-Montage Standard Electroencephalograph
GWR
Generator, Electroencephalograph Test Signal
GWS
Analyzer, Spectrum, Electroencephalogram Signal
GWW
Ataxiagraph
GWX
Fork, Tuning
GWY
Pinwheel
GWZ
Percussor
GXB
Esthesiometer
GYB
Media, Electroconductive
GYC
Electrode, Cortical
GYD
Transducer, Tremor
GYE
Encephalogram Telemetry System
GZK
Electrode, Nasopharyngeal
GZL
Electrode, Depth
GZM
Analyzer, Rigidity
GZN
Rheoencephalograph
GZO
Device, Galvanic Skin Response Measurement
GZP
Stimulator, Mechanical, Evoked Response
HCJ
Device, Skin Potential Measurement
HCS
Device, Temperature Measurement, Direct Contact, Powered
JXE
Device, Nerve Conduction Velocity Measurement
JXF
Plethysmograph, Ocular
LLN
Device, Vibration Threshold Measurement
LQW
Test, Temperature Discrimination
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
NTU
Evoked Potential Stimulator, Thermal
OLT
Non-Normalizing Quantitative Electroencephalograph Software
OLU
Normalizing Quantitative Electroencephalograph Software
OLV
Standard Polysomnograph With Electroencephalograph
OLW
Index-Generating Electroencephalograph Software
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
OLY
Magnetoencephalograph
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
OMA
Amplitude-Integrated Electroencephalograph
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
OMC
Reduced- Montage Standard Electroencephalograph
ORT
Burst Suppression Detection Software For Electroencephalograph
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PKQ
Computerized Cognitive Assessment Aid
PNA
Evoked Photon Image Capture Device
POM
Computerized Cognitive Assessment Aid For Concussion
POP
Cranial Motion Measurement Device
POS
Physiological Signal Based Seizure Monitoring System
PSP
Intracranial Pressure & Temperature Monitoring Kit
PTB
Ataxiagraph With Interpretive Software
PTY
Computerized Cognitive Assessment Aid, Exempt
PVP
Neurological Test Kit
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
OPT
Infrared Hematoma Detector
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—neurological-diagnostic-devices
/
GWG
/
K934154
View Source
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K934154
510(k) Type
Traditional
Applicant
NEURO NAVIGATIONAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/21/1995
Days to Decision
543 days
Submission Type
Statement