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

    VISIONSENSE STEREOSCOPIC VISION SYSTEM

    K Number: K082355 · Decision Dec 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    13
    Review Days
    122

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    Basic Information

    Device Name
    VISIONSENSE STEREOSCOPIC VISION SYSTEM
    K Number
    K082355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visionsense, Ltd.
    Date Received
    August 15, 2008
    Decision Date
    December 15, 2008
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Visionsense, Ltd.

    K Number Device Name
    K223020 VS3-Iridium System (VS3-IR)
    K210265 VS3 Iridium Sytem
    K171208 Trans-anal Introducer
    K153548 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
    K152204 VS3-IR system
    K150018 VS3-IR-MMS System
    K141002 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
    K131434 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
    K123467 VS3
    K082667 VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
    Search all 13 clearances from Visionsense, Ltd. →