BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇳 China

    Endura™ Ureteral Stent and Stent Set

    K Number: K251469 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    2
    Review Days
    220

    Basic Information

    Device Name
    Endura™ Ureteral Stent and Stent Set
    K Number
    K251469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Cathegenix (Xiamen) Co., Ltd.
    Date Received
    May 13, 2025
    Decision Date
    December 19, 2025
    Product Code
    FAD
    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
    FAD Stent, Ureteral

    Similar 510(k) Clearances

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

    Disposable Ureteral Stents

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

    Ureteral Stents (AF-D series)

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

    Disposable ureteral stent

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

    Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set

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

    RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

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

    APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

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

    Other Clearances by Cathegenix (Xiamen) Co., Ltd.

    K Number Device Name
    K250585 LumenaTM Ureteral Access Sheath