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

    RADIUS LOW PROFILE GASTROSTOMY TUBE KIT

    K Number: K971901 · Decision Jan 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    5
    Review Days
    244

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    Basic Information

    Device Name
    RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
    K Number
    K971901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radius Intl., Inc.
    Date Received
    May 23, 1997
    Decision Date
    January 22, 1998
    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 Radius Intl., Inc.

    K Number Device Name
    K972102 RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
    K972025 RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
    K951560 RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
    K930510 RADIUS ENTERAL FEEDING TUBE