BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MED-RX ORAL/ENTERAL SYRINGE

    K Number: K131183 · Decision Jun 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    403

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    Basic Information

    Device Name
    MED-RX ORAL/ENTERAL SYRINGE
    K Number
    K131183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benlan, Inc.
    Date Received
    April 26, 2013
    Decision Date
    June 3, 2014
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Benlan, Inc.

    K Number Device Name
    K120375 MED-RX PATIENT DELIVERY SET
    K112799 MED-RX EXTENSION SET WITH T-CONNECTOR
    K100700 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
    K102073 MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
    K010607 MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
    K990777 MED-RX EXTENSION SETS