BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    K Number: K022554 · Decision Aug 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    8
    Review Days
    21

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    Basic Information

    Device Name
    MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
    K Number
    K022554
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Neurosciences
    Date Received
    August 2, 2002
    Decision Date
    August 23, 2002
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Integra Neurosciences

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    K031086 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
    K021989 SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
    K022553 CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
    K020558 LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
    K002765 LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE