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

    WIJAY EZ-VOID EXTERNAL CATHETER VALVE

    K Number: K140562 · Decision Jun 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    103

    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
    WIJAY EZ-VOID EXTERNAL CATHETER VALVE
    K Number
    K140562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Leomed, LLC
    Date Received
    March 5, 2014
    Decision Date
    June 16, 2014
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

    Similar 510(k) Clearances

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

    Bi-Flex Evo

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

    Vesair Cystoscopic Sheath

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

    BI-FLEX URETERAL ACCESS SHEATH

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

    GUARDIAN URETHRAL SHEATH

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

    GUARDIAN URETHRAL SHEATH

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

    VARI-PASS VARIABLE LENGTH ACCESS SHEATH

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