BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    SB Soft Hood - Straight type, SB Soft Hood - Undercut type

    K Number: K173004 · Decision May 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    4
    Review Days
    223

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    Basic Information

    Device Name
    SB Soft Hood - Straight type, SB Soft Hood - Undercut type
    K Number
    K173004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sumitomo Bakelite Co., Ltd.
    Date Received
    September 27, 2017
    Decision Date
    May 8, 2018
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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    Other Clearances by Sumitomo Bakelite Co., Ltd.

    K Number Device Name
    K182520 Flexible Overtube
    K190621 SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
    K152771 SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long