BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Intermittent Catheter (TPU Catheter)

    K Number: K243175 · Decision Jun 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    269

    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
    Disposable Intermittent Catheter (TPU Catheter)
    K Number
    K243175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chengdu Daxan Innovative Medical Tech. Co., Ltd.
    Date Received
    September 30, 2024
    Decision Date
    June 26, 2025
    Product Code
    EZD
    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
    EZD Catheter, Straight

    Similar 510(k) Clearances

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

    Coude Sleeved IC; Coude Plus Sleeved IC

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

    LoFric Elle Pro

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

    GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

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

    Liv Pre-lubricated Intermittent Catheter

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

    EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

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

    Ready to use Nelaton Catheter

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

    Other Clearances by Chengdu Daxan Innovative Medical Tech. Co., Ltd.

    K Number Device Name
    K212567 PVC Hydrophilic Urethral Catheter