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

    RADIUS ENTERAL FEEDING TUBE

    K Number: K930510 · Decision Feb 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    730

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    Basic Information

    Device Name
    RADIUS ENTERAL FEEDING TUBE
    K Number
    K930510
    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
    February 1, 1993
    Decision Date
    February 1, 1995
    Product Code
    BSS
    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
    BSS Tube, Nasogastric

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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
    K971901 RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
    K951560 RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)