Device, Monitoring, Intracranial Pressure

Device Code: 3644

Product Code(s): GWM

Device Classification Information

Device Type ID3644
Device NameDevice, Monitoring, Intracranial Pressure
Regulation DescriptionIntracranial Pressure Monitoring Device.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.1620 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGWM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3644
DeviceDevice, Monitoring, Intracranial Pressure
Product CodeGWM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntracranial Pressure Monitoring Device.
CFR Regulation Number882.1620 [🔎]
Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
HEMEDEX INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
INNERSPACE NEURO SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA
 
SUBSTANTIALLY EQUIVALENT
 2
INTEGRA LIFESCIENCES CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA LIFESCIENCES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
JOHNSON & JOHNSON PROFESSIONALS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDOS INTERNATIONAL SARL
 
SUBSTANTIALLY EQUIVALENT
 1
RAUMEDIC AG
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Device Operates Differently Than Expected
 129
Incorrect, Inadequate Or Imprecise Result Or Readings
 116
Break
 98
Low Readings
 70
Device Operational Issue
 69
Device Displays Incorrect Message
65
Use Of Device Problem
 60
Disconnection
 58
Unable To Obtain Readings
53
High Readings
 49
Adverse Event Without Identified Device Or Use Problem
 49
Incorrect Measurement
 46
Fluid Leak
 37
Leak / Splash
 36
Appropriate Term/Code Not Available
 33
Display Or Visual Feedback Problem
 31
Failure To Zero
 29
Signal Artifact
 27
False Reading From Device Non-Compliance
 21
Connection Problem
 20
Device Handling Problem
 19
Fracture
 18
Device Sensing Problem
 16
Electrical /Electronic Property Problem
 16
Insufficient Information
 16
Failure To Power Up
 15
No Display / Image
 15
Device Inoperable
 13
Improper Device Output
 12
Crack
 11
Output Problem
 10
Erratic Or Intermittent Display
 9
Catheter
 9
Improper Or Incorrect Procedure Or Method
 8
Defective Device
 8
Device Issue
 8
Loss Of Power
 7
Pressure Problem
 7
No Device Output
7
Device Stops Intermittently
 7
Cable
 7
Occlusion Within Device
 7
Device Difficult To Program Or Calibrate
 7
Screen
 6
Battery Problem
 6
Loose Or Intermittent Connection
 6
Image Display Error / Artifact
 6
Device Damaged Prior To Use
5
Device Or Device Fragments Location Unknown
 5
Incorrect Or Inadequate Test Results
 5
Power Problem
 5
Product Quality Problem
 5
Failure To Sense
5
Communication Or Transmission Problem
 5
Defective Component
 4
Invalid Sensing
 4
Temperature Problem
 4
Grounding Malfunction
 4
Mechanical Jam
 4
Out-Of-Box Failure
 4
Material Separation
 3
Patient Data Problem
 3
Material Deformation
 3
Monitor
 3
Calibration Problem
 3
Device Difficult To Setup Or Prepare
 3
Failure To Advance
 3
Material Discolored
 3
Display Difficult To Read
3
Issue With Displayed Error Message
 3
Material Integrity Problem
 3
Migration Or Expulsion Of Device
3
Difficult To Remove
2
Bent
 2
Charging Problem
2
Data Problem
 2
Battery
 2
Material Puncture / Hole
 2
Failure To Calibrate
 2
Activation, Positioning Or Separation Problem
 2
No Audible Alarm
 2
High Test Results
 2
Fiberoptic
 2
Overheating Of Device
 2
Mechanical Problem
 2
Display
 2
Torn Material
 2
Packaging Problem
 2
Improper Flow Or Infusion
 2
Imprecision
2
Connector
 2
Sensor
 2
Device Alarm System
 2
Low Battery
 2
Detachment Of Device Component
 2
Plug
 2
Low Test Results
 2
Unintended Movement
 2
Device Contamination With Chemical Or Other Material
 2
Improper Alarm
 2
Total Device Problems 1523
Recalls
Manufacturer Recall Class Date Posted
1
Integra LifeSciences Corp.
 II Jun-18-2015
2
Integra LifeSciences Corp.
 II May-15-2015
3
Integra LifeSciences Corp.
 II Dec-18-2014
4
Integra LifeSciences Corp.
 II Nov-10-2014
5
Integra LifeSciences Corp.
 II May-30-2014
6
Spiegelberg Gmbh & Co. KG
 II Sep-26-2016
TPLC Last Update: 2019-04-02 20:33:43
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