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

    Optilume Basic Urological Balloon Dilation Catheter

    K Number: K191061 · Decision Jan 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    255

    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
    Optilume Basic Urological Balloon Dilation Catheter
    K Number
    K191061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Urotronic, Inc.
    Date Received
    April 22, 2019
    Decision Date
    January 2, 2020
    Product Code
    KOE
    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
    KOE Dilator, Urethral

    Similar 510(k) Clearances

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

    ATRION MEDICAL QL INFLATION DEVICE

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

    ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE

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

    BARD EAGLE INFLATION DEVICE

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

    AQ HYDROPHILIC DILATORS

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

    U.S. MEDICAL PS-7000 DIALYSIS SCALE

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

    120 FR OPTILUME PROSTATE BALLOON DILATOR

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

    Other Clearances by Urotronic, Inc.

    K Number Device Name
    K250910 Optilume® High Pressure Urological Balloon Dilation Catheter