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

    EndoGI S-Path Biliary Stent System

    K Number: K202477 · Decision Sep 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    2
    Review Days
    27

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EndoGI S-Path Biliary Stent System
    K Number
    K202477
    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 28, 2020
    Decision Date
    September 24, 2020
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.

    Dilation Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoflux™ Biliary & Pancreatic Stent Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BARE Wireguided Balloon Dilation Catheter (1235)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single use stone retrieval balloons

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Endo GI Medical

    K Number Device Name
    K222627 EndoGI S-Path Biliary Stent System