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

    Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

    K Number: K171347 · Decision Jun 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    3
    Review Days
    29

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    Basic Information

    Device Name
    Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
    K Number
    K171347
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xeridiem Medical Devices
    Date Received
    May 8, 2017
    Decision Date
    June 6, 2017
    Product Code
    PIF
    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
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by Xeridiem Medical Devices

    K Number Device Name
    K130674 ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
    K130611 ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE