BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    URETERAL CATHETER AND ACCESSORIES

    K Number: K934419 · Decision May 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    254

    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
    URETERAL CATHETER AND ACCESSORIES
    K Number
    K934419
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Urological Associates of Central Jersey P.A.
    Date Received
    September 13, 1993
    Decision Date
    May 25, 1994
    Product Code
    EYK
    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
    EYK Connector, Ureteral Catheter