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

    10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

    K Number: K081733 · Decision Oct 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    430
    Review Days
    130

    Basic Information

    Device Name
    10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
    K Number
    K081733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON SCIENTIFIC CORP.
    Date Received
    June 19, 2008
    Decision Date
    October 27, 2008
    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 BOSTON SCIENTIFIC CORP.

    K Number Device Name
    K152853 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
    K150692 AXIOS Stent with Electrocautery Enhanced Delivery System
    K150303 XXL Vascular Balloon Dilatation Catheter
    K150186 Chariot Guiding Sheath
    K150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
    K141820 JAGWIRE HIGH PERFORMANCE GUIDWIRE
    K141335 EXPEL APD DRAINAGE CATHETER SYSTEM
    K141344 EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
    K141150 PTA BALLOON DILATATION CATHETER
    K142259 Direxion Torqueable Microcatheter
    Search all 430 clearances from BOSTON SCIENTIFIC CORP. →