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

    Vesco Medical Extension Feeding Set

    K Number: K192991 · Decision Aug 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    4
    Review Days
    283

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    Basic Information

    Device Name
    Vesco Medical Extension Feeding Set
    K Number
    K192991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vesco Medical, LLC
    Date Received
    October 25, 2019
    Decision Date
    August 3, 2020
    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 Vesco Medical, LLC

    K Number Device Name
    K232205 Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set
    K170162 Vesco Medical Nasoenteric Feeding Tubes
    K170218 Vesco Medical NRFit Tip Syringes