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

    IMPROVED BAKER TWIN-CUFF SUMP TUBE

    K Number: K901683 · Decision Jun 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    6
    Review Days
    78

    Basic Information

    Device Name
    IMPROVED BAKER TWIN-CUFF SUMP TUBE
    K Number
    K901683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    BISSELL MEDICAL PRODUCTS, INC.
    Date Received
    April 10, 1990
    Decision Date
    June 27, 1990
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by BISSELL MEDICAL PRODUCTS, INC.

    K Number Device Name
    K932880 GRASSI GASTROJEJUNOSTOMY TUBE
    K914140 GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED
    K873441 BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE
    K871691 MODIFIED MULTI-LUMEN NASOGASTRIC TUBE
    K851672 NYHUS/NELSON TUBE