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

    AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET

    K Number: K120272 · Decision Feb 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    6
    Review Days
    18

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    Basic Information

    Device Name
    AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
    K Number
    K120272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kentec Medical, Inc.
    Date Received
    January 30, 2012
    Decision Date
    February 17, 2012
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    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 Kentec Medical, Inc.

    K Number Device Name
    K100526 AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
    K050443 ACCU-LEAD
    K970686 ACCUTEMP-PROBE
    K960080 ACCUTEMP PROBE
    K853475 GRAM-MA NEONATAL SC