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

    Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter

    K Number: K171548 · Decision Oct 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    10
    Review Days
    140

    Basic Information

    Device Name
    Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
    K Number
    K171548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    May 26, 2017
    Decision Date
    October 13, 2017
    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.

    Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers

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

    EGIS Biliary Double Bare Stent (BDB080405)

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

    Single-use Balloon Dilatation Catheter

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

    Tornus ES

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

    WallFlex Biliary PLUS RX Stent System

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

    WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV

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

    Other Clearances by Wilson-Cook Medical, Inc.

    K Number Device Name
    K213356 Entuit PEG, Entuit PEGJ
    K192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
    K191048 AcuSnare Polypectomy Snare - Duckbill
    K181317 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
    K182319 Glo-Tip Spray Catheter
    K171969 Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
    K171973 Captura® Disposable Hot Biopsy Forceps
    K171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
    K160170 Lehman Manometry Catheter