BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    NAVIAID ICVI DEVICE

    K Number: K101191 · Decision Jul 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    NAVIAID ICVI DEVICE
    K Number
    K101191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smart Medical Systems , Ltd.
    Date Received
    April 28, 2010
    Decision Date
    July 27, 2010
    Product Code
    FDF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by Smart Medical Systems , Ltd.

    K Number Device Name
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    K202469 G-EYE System
    K192588 G-EYE System
    K112106 NAVIAID ICVI-F,S,B,R DEVICE
    K111760 NAVIAID(TM) BGC DEVICE
    K110291 NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
    K102616 NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
    K060923 NAVIAID BGE DEVICE, MODEL 21-001