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

    Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

    K Number: K180708 · Decision Oct 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    213

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    Basic Information

    Device Name
    Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
    K Number
    K180708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Xeridiem Medical Devices, A Spectrum Plastics Group Company
    Date Received
    March 19, 2018
    Decision Date
    October 18, 2018
    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, A Spectrum Plastics Group Company

    K Number Device Name
    K232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection