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    K Number
    K173004
    Device Name
    SB Soft Hood - Straight type, SB Soft Hood - Undercut type
    Manufacturer
    Sumitomo Bakelite Co., Ltd
    Date Cleared
    2018-05-08

    (223 days)

    Product Code
    FDS
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sumitomo Bakelite Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.
    Device Description
    SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinatter ESD) procedures. The subject device is used for maintaining visualization during the dissection phase of the procedure. The subject device is disposable and in a variety of diameters that correspond to different endoscope sizes. Each model of the subject device contains a drainage side hole that allows egress of water and blood.
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