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

    Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

    K Number: K143609 · Decision Mar 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    12
    Review Days
    98

    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
    Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
    K Number
    K143609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Surgical Technologies America
    Date Received
    December 19, 2014
    Decision Date
    March 27, 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 Olympus Surgical Technologies America

    K Number Device Name
    K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
    K212643 POWERSEAL Curved Jaw Sealer and Divider, Double Action
    K193517 ViziShot 2 FLEX
    K183647 SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
    K190164 CleverLock Guidewire Locking Device and Biopsy Cap
    K181193 PeriView FLEX
    K171232 PeriView FLEX
    K163469 ViziShot 2 FLEX
    K132181 GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
    K123170 VARI-PASS VARIABLE LENGTH ACCESS SHEATH
    Search all 12 clearances from Olympus Surgical Technologies America →