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

    BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE

    K Number: K142075 · Decision Jan 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    161

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
    K Number
    K142075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xeridiem (Formerly Mri)
    Date Received
    July 31, 2014
    Decision Date
    January 8, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PIF), ordered by most recent decision date.

    Percutaneous Endoscopic Gastrostomy (PEG) Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Enteral Drainage System, Enteral Medicine straw

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Extension Feeding Set with ENFit™ Connectors

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Disposable Enteral Feeding Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Mobility+ Enteral Feeding System OTC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENFit to ENFit Extension Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Xeridiem (Formerly Mri)

    K Number Device Name
    K142297 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set