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

    Aurie System

    K Number: DEN250023 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    328

    Basic Information

    Device Name
    Aurie System
    K Number
    DEN250023
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5120
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Cathbuddy, Inc.
    Date Received
    June 6, 2025
    Decision Date
    April 30, 2026
    Product Code
    SHV
    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
    SHV Reusable Intermittent Urinary Catheter System