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

    SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

    K Number: K013488 · Decision Mar 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    9
    Review Days
    159

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    Basic Information

    Device Name
    SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
    K Number
    K013488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sophysa SA
    Date Received
    October 19, 2001
    Decision Date
    March 27, 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 Sophysa SA

    K Number Device Name
    K162108 Pressio 2 ICP Monitoring System
    K141227 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
    K091328 SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
    K090342 POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
    K062584 PRESSIO ICP MONITORING SYSTEM
    K042481 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
    K031097 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
    K992465 SOPHY SU8 PRESSURE ADJUSTABLE VALVE