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

    Entarik NI Feeding Tube System

    K Number: K241169 · Decision Nov 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    Entarik NI Feeding Tube System
    K Number
    K241169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gravitas Medical, Inc.
    Date Received
    April 26, 2024
    Decision Date
    November 22, 2024
    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 Gravitas Medical, Inc.

    K Number Device Name
    K230206 Entarik Feeding Tube System; Entarik Feeding Tube