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

    GASTROSTOMY FEEDING TUBE

    K Number: K883336 · Decision Aug 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    GASTROSTOMY FEEDING TUBE
    K Number
    K883336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gastrotech, Inc.
    Date Received
    August 9, 1988
    Decision Date
    August 23, 1988
    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 Gastrotech, Inc.

    K Number Device Name
    K890658 SYRINGE INJECTION GUN DELIVERY KITS
    K890629 ESOPHAGEAL OVERTUBE
    K883351 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE
    K862853 SYRINGE INJECTION GUN