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

    PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

    K Number: K043254 · Decision Feb 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    78

    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
    PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
    K Number
    K043254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Onset Medical Corporation
    Date Received
    November 24, 2004
    Decision Date
    February 10, 2005
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

    Similar 510(k) Clearances

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

    Optilume® High Pressure Urological Balloon Dilation Catheter

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

    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

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

    In-Ka Ureteral Balloon Dilatation Catheter

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

    EQUINOX Balloon Dilatation Catheter

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

    Ureteral Dilator Sets, Ureteral Dilators

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

    Safety Wire Guide Introducer

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

    Other Clearances by Onset Medical Corporation

    K Number Device Name
    K152498 SoloPath Re-Collapsible Access System
    K121404 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
    K112629 ONSET ACCESS CATHETER SYSTEM
    K100819 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K092014 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
    K062852 BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
    K061009 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS