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

    EndoGI S-Path Biliary Stent System

    K Number: K222627 · Decision Sep 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    EndoGI S-Path Biliary Stent System
    K Number
    K222627
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo GI Medical
    Date Received
    August 31, 2022
    Decision Date
    September 28, 2022
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Endo GI Medical

    K Number Device Name
    K202477 EndoGI S-Path Biliary Stent System