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

    3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

    K Number: K022287 · Decision Sep 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    5
    Review Days
    70

    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
    3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
    K Number
    K022287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    3t Medical Systems, LLC
    Date Received
    July 15, 2002
    Decision Date
    September 23, 2002
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

    Similar 510(k) Clearances

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

    Rusch SoftSimplastic Foley Catheters

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

    Silicone Urethral Catheter (Silicone Urethral Catheter)

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

    InnoCare Specialty Foley Catheter

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

    Rüsch Latex Gold Foley Catheter

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

    TraumaGuard Intra-abdominal Pressure Sensing System

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

    Folysil Silicone Catheter

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

    Other Clearances by 3t Medical Systems, LLC

    K Number Device Name
    K072697 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
    K020768 3T VESSEL CANNULAS
    K020365 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
    K001245 3T L. V. CONTROL VALVE