BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Percutaneous Endoscopic Gastrostomy (PEG) Kit

    K Number: K254170 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    19
    Review Days
    87

    Basic Information

    Device Name
    Percutaneous Endoscopic Gastrostomy (PEG) Kit
    K Number
    K254170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Degania Silicone , Ltd.
    Date Received
    December 23, 2025
    Decision Date
    March 20, 2026
    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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