FDA Browser
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
Review Panel
Neurology
Review Panel
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
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
K
24
0821
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
2
Cleared 510(K)
K
23
2890
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
2
Cleared 510(K)
K
20
1989
B4C System
2
Cleared 510(K)
K
21
0993
CereLink ICP Monitor
2
Cleared 510(K)
K
20
1118
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
2
Cleared 510(K)
K
20
0630
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
2
Cleared 510(K)
K
20
0456
Becker External Drainage and Monitoring System
2
Cleared 510(K)
K
18
2073
BcSs-PICNI-2000 Sensor
2
Cleared 510(K)
K
18
3406
CereLink ICP Monitor, CereLink ICP Extension Cable
2
Cleared 510(K)
K
17
2209
AURA ICP MONITORING SYSTEM
2
Cleared 510(K)
K
17
3192
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
2
Cleared 510(K)
K
17
1666
MPR2 logO DATALOGGER
2
Cleared 510(K)
K
16
2108
Pressio 2 ICP Monitoring System
2
Cleared 510(K)
K
16
1010
HICP200 Patient/Monitor Interconnect Cable
2
Cleared 510(K)
K
15
3347
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
2
Cleared 510(K)
K
15
2670
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
2
Cleared 510(K)
K
14
1869
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
2
Cleared 510(K)
K
13
3754
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
2
Cleared 510(K)
K
13
0529
RAUMEDIC-PTO-MONITORING-SYSTEM
2
Cleared 510(K)
K
13
1184
INTEGRA LICOX PTO2 MONITOR
2
Cleared 510(K)
K
12
1573
INTEGRA CAMINO ICP MONITOR
2
Cleared 510(K)
K
12
1159
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
2
Cleared 510(K)
K
11
3088
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
2
Cleared 510(K)
K
12
0252
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
2
Cleared 510(K)
K
11
2017
RAUMEDIC ICP MONITORING SYSTEM
2
Cleared 510(K)
K
10
3206
RAUMEDIC- ICP-MONITORING SYSTEM
2
Cleared 510(K)
K
10
2077
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
2
Cleared 510(K)
K
10
2875
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
2
Cleared 510(K)
K
10
1133
SENSOMETRICS SOFTWARE
2
Cleared 510(K)
K
08
3378
SYNERGY
2
Cleared 510(K)
K
07
1984
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
2
Cleared 510(K)
K
07
2379
MPS OXIPORT AND MPS OXIPORT PLUS
2
Cleared 510(K)
K
07
1505
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
2
Cleared 510(K)
K
06
2584
PRESSIO ICP MONITORING SYSTEM
2
Cleared 510(K)
K
06
1640
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
2
Cleared 510(K)
K
05
3244
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
2
Cleared 510(K)
K
06
0554
CMA CEREBRAL TISSUE MONITORING SYSTEM
2
Cleared 510(K)
K
05
1599
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
2
Cleared 510(K)
K
05
0702
NEUROSYSTEMS 1TM MONITOR
2
Cleared 510(K)
K
05
0720
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
2
Cleared 510(K)
K
04
1838
MPS (OR MPS-T)
2
Cleared 510(K)
K
04
2728
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
2
Cleared 510(K)
K
04
0235
LICOX PMO BRAIN MONITORING SYSTEM
2
Cleared 510(K)
K
03
2337
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
2
Cleared 510(K)
K
03
1086
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
2
Cleared 510(K)
K
02
2638
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
2
Cleared 510(K)
K
02
0285
CMA CEREBRAL TISSUE MONITORING SYSTEM
2
Cleared 510(K)
K
01
3705
ACT III VENTRICULAR CATHETER
2
Cleared 510(K)
K
02
2553
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
2
Cleared 510(K)
K
02
0780
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
2
Cleared 510(K)
K
02
0558
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
2
Cleared 510(K)
K
01
3930
NEUROSENSOR
2
Cleared 510(K)
K
01
0422
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
2
Cleared 510(K)
K
00
3759
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
2
Cleared 510(K)
K
00
3905
ACTI-ICP MONITORING SYSTEM
2
Cleared 510(K)
K
00
2765
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
2
Cleared 510(K)
K
00
2392
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
2
Cleared 510(K)
K
99
2591
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
2
Cleared 510(K)
K
98
0380
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
2
Cleared 510(K)
K
99
1222
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
2
Cleared 510(K)
K
98
3799
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
2
Cleared 510(K)
K
98
2702
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
2
Cleared 510(K)
K
98
1846
PARENCHYMAL BOLT PRESSURE MONITORING KIT
2
Cleared 510(K)
K
97
4088
CODMAN INTRACRANIAL BOLT
2
Cleared 510(K)
K
96
2928
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
2
Cleared 510(K)
K
94
5585
COMAN(R) CU-11 MODEL NUMBER 82-6634
2
Cleared 510(K)
K
93
1609
CHARTR ENG SYSTEM
2
Cleared 510(K)
K
94
0648
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
2
Cleared 510(K)
K
94
3987
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
2
Cleared 510(K)
K
91
4479
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
2
Cleared 510(K)
K
93
0221
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
2
Cleared 510(K)
K
91
2139
MODEL 704
2
Cleared 510(K)
K
91
4735
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
2
Cleared 510(K)
K
88
4823
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
2
Cleared 510(K)
K
89
6834
MODEL BT-1 FOT BOLT INSTALLATION KIT
2
Cleared 510(K)
K
89
3395
MINI-MONITOR J7000 ICP
2
Cleared 510(K)
K
89
0468
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
2
Cleared 510(K)
K
88
3881
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
2
Cleared 510(K)
K
88
3518
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
2
Cleared 510(K)
K
88
2552
METATECH ROBINSON BOLT ACCESSORY
2
Cleared 510(K)
K
88
3115
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
2
Cleared 510(K)
K
88
2286
EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
2
Cleared 510(K)
K
88
1183
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
2
Cleared 510(K)
K
88
0154
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
2
Cleared 510(K)
K
86
2820
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
2
Cleared 510(K)
K
86
3479
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
2
Cleared 510(K)
K
85
3770
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
2
Cleared 510(K)
K
86
2012
LADD MEDICAL S-2000
2
Cleared 510(K)
K
85
3864
INTRACRANIAL PRESSURE MONITORING KIT 070
2
Cleared 510(K)
K
85
4657
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
2
Cleared 510(K)
K
84
4566
ICP MONITOR MODEL 1000
2
Cleared 510(K)
K
84
0999
PHILLY INFANT BOLT
2
Cleared 510(K)
K
84
0003
DISPOSABLE ICP KIT DIFF. SIZES
2
Cleared 510(K)
K
82
2864
INTRACRANIAL PRESSURE MONITORING DEVICE
2
Cleared 510(K)
K
82
2636
CLASS II DEVICE FOR I.C.P. MONITORING
2
Cleared 510(K)
K
81
3440
PHILLY BOLT
2
Cleared 510(K)
K
80
2149
TM-5 INTRACRANIAL PRESSURE MONITOR
2
Cleared 510(K)
K
80
2138
CHEEK TOOL SET
2
Cleared 510(K)
K
80
2137
CHEEK EPIDURAL SCREW
2
Cleared 510(K)
K
80
2100
INTRACRANIAL PRESSURING MONITORING SYST.
2
Cleared 510(K)
K
80
1755
MMI/GAELTEC CATHETER TIP PRESSURE
2
Cleared 510(K)
K
79
0920
INTRACRANIAL PRESSURE MONITORING
2
Cleared 510(K)
K
77
2063
CATHETER, INTRACRANIAL PRESS. MONITOR.
2
Cleared 510(K)
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
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
NE
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subpart-b—neurological-diagnostic-devices
/
GWM
/
K992591
View Source
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992591
510(k) Type
Traditional
Applicant
Codman & Shurtleff, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1999
Days to Decision
74 days
Submission Type
Summary
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
GWI
Discriminator, Two-Point
GWJ
Stimulator, Auditory, Evoked Response
GWK
Conditioner, Signal, Physiological
GWL
Amplifier, Physiological Signal
GWM
Device, Monitoring, Intracranial Pressure
K
24
0821
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K
23
2890
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K
20
1989
B4C System
K
21
0993
CereLink ICP Monitor
K
20
1118
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
K
20
0630
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K
20
0456
Becker External Drainage and Monitoring System
K
18
2073
BcSs-PICNI-2000 Sensor
K
18
3406
CereLink ICP Monitor, CereLink ICP Extension Cable
K
17
2209
AURA ICP MONITORING SYSTEM
K
17
3192
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K
17
1666
MPR2 logO DATALOGGER
K
16
2108
Pressio 2 ICP Monitoring System
K
16
1010
HICP200 Patient/Monitor Interconnect Cable
K
15
3347
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
K
15
2670
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
K
14
1869
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K
13
3754
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K
13
0529
RAUMEDIC-PTO-MONITORING-SYSTEM
K
13
1184
INTEGRA LICOX PTO2 MONITOR
K
12
1573
INTEGRA CAMINO ICP MONITOR
K
12
1159
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
K
11
3088
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K
12
0252
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K
11
2017
RAUMEDIC ICP MONITORING SYSTEM
K
10
3206
RAUMEDIC- ICP-MONITORING SYSTEM
K
10
2077
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K
10
2875
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
K
10
1133
SENSOMETRICS SOFTWARE
K
08
3378
SYNERGY
K
07
1984
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K
07
2379
MPS OXIPORT AND MPS OXIPORT PLUS
K
07
1505
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K
06
2584
PRESSIO ICP MONITORING SYSTEM
K
06
1640
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K
05
3244
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K
06
0554
CMA CEREBRAL TISSUE MONITORING SYSTEM
K
05
1599
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K
05
0702
NEUROSYSTEMS 1TM MONITOR
K
05
0720
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K
04
1838
MPS (OR MPS-T)
K
04
2728
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K
04
0235
LICOX PMO BRAIN MONITORING SYSTEM
K
03
2337
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K
03
1086
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K
02
2638
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K
02
0285
CMA CEREBRAL TISSUE MONITORING SYSTEM
K
01
3705
ACT III VENTRICULAR CATHETER
K
02
2553
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
K
02
0780
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K
02
0558
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K
01
3930
NEUROSENSOR
K
01
0422
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
K
00
3759
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K
00
3905
ACTI-ICP MONITORING SYSTEM
K
00
2765
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
K
00
2392
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K
99
2591
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K
98
0380
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K
99
1222
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K
98
3799
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
K
98
2702
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K
98
1846
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K
97
4088
CODMAN INTRACRANIAL BOLT
K
96
2928
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K
94
5585
COMAN(R) CU-11 MODEL NUMBER 82-6634
K
93
1609
CHARTR ENG SYSTEM
K
94
0648
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K
94
3987
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
K
91
4479
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K
93
0221
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K
91
2139
MODEL 704
K
91
4735
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K
88
4823
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K
89
6834
MODEL BT-1 FOT BOLT INSTALLATION KIT
K
89
3395
MINI-MONITOR J7000 ICP
K
89
0468
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
K
88
3881
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
K
88
3518
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
K
88
2552
METATECH ROBINSON BOLT ACCESSORY
K
88
3115
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K
88
2286
EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
K
88
1183
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K
88
0154
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
K
86
2820
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
K
86
3479
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
K
85
3770
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K
86
2012
LADD MEDICAL S-2000
K
85
3864
INTRACRANIAL PRESSURE MONITORING KIT 070
K
85
4657
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K
84
4566
ICP MONITOR MODEL 1000
K
84
0999
PHILLY INFANT BOLT
K
84
0003
DISPOSABLE ICP KIT DIFF. SIZES
K
82
2864
INTRACRANIAL PRESSURE MONITORING DEVICE
K
82
2636
CLASS II DEVICE FOR I.C.P. MONITORING
K
81
3440
PHILLY BOLT
K
80
2149
TM-5 INTRACRANIAL PRESSURE MONITOR
K
80
2138
CHEEK TOOL SET
K
80
2137
CHEEK EPIDURAL SCREW
K
80
2100
INTRACRANIAL PRESSURING MONITORING SYST.
K
80
1755
MMI/GAELTEC CATHETER TIP PRESSURE
K
79
0920
INTRACRANIAL PRESSURE MONITORING
K
77
2063
CATHETER, INTRACRANIAL PRESS. MONITOR.
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
/
GWM
/
K992591
View Source
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992591
510(k) Type
Traditional
Applicant
Codman & Shurtleff, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1999
Days to Decision
74 days
Submission Type
Summary