BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    S698 Symbioz flow

    K Number: K153367 · Decision Jun 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    4
    Review Days
    207

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    Basic Information

    Device Name
    S698 Symbioz flow
    K Number
    K153367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sopro - Acteon Group
    Date Received
    November 23, 2015
    Decision Date
    June 17, 2016
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    Other Clearances by Sopro - Acteon Group

    K Number Device Name
    K142995 SOPIX
    K151053 PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
    K140013 SOPIX INSIDE, SOPIX2 INSIDE