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

    AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

    K Number: K100526 · Decision Apr 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
    K Number
    K100526
    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
    February 24, 2010
    Decision Date
    April 22, 2010
    Product Code
    FPD
    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
    FPD Tube, Feeding

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    Other Clearances by Kentec Medical, Inc.

    K Number Device Name
    K120272 AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
    K050443 ACCU-LEAD
    K970686 ACCUTEMP-PROBE
    K960080 ACCUTEMP PROBE
    K853475 GRAM-MA NEONATAL SC