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

    FOLEY CATHETERS WITH TEMPERATURE PROBE

    K Number: K061918 · Decision Aug 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    168
    Review Days
    43

    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
    FOLEY CATHETERS WITH TEMPERATURE PROBE
    K Number
    K061918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Healthcare
    Date Received
    July 6, 2006
    Decision Date
    August 18, 2006
    Product Code
    EYC
    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
    EYC Catheter, Upper Urinary Tract

    Similar 510(k) Clearances

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

    Foley Catheter with Temperature Sensor

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

    EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER

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

    EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S

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

    STERILE FOLEY CATHETER

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

    Other Clearances by GE Healthcare

    K Number Device Name
    K253639 View
    K242925 MR Contour DL
    K232346 Digital Expert Access with Remote Scanning
    K223212 Precision DL
    K221680 Xeleris V Processing and Review System
    K221932 Omni Legend
    K213689 Voluson P6, Voluson P8
    K213642 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
    K211488 LOGIQ E10
    K211524 LOGIQ E10s, LOGIQ Fortis
    Search all 168 clearances from GE Healthcare →