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

    Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter

    K Number: K152069 · Decision Sep 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    35
    Review Days
    59

    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
    Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
    K Number
    K152069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navilyst Medical, Inc.
    Date Received
    July 27, 2015
    Decision Date
    September 24, 2015
    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 Navilyst Medical, Inc.

    K Number Device Name
    K163452 PICC Maximal Barrier Nursing Kit
    K161866 BioFlo Midline Catheter
    K151239 NMI DUAL PORT II
    K153228 NMI Port, NMI Port II
    K152409 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
    K150407 BioFlo Midline Catheter
    K150527 Xcela Power Injectable PICC
    K150448 NMI PICC III and NMI PICC IV
    K142616 PICC Maximal Barrier Nursing Kit
    K140194 NAMIC RCS SYRINGE
    Search all 35 clearances from Navilyst Medical, Inc. →