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

    KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

    K Number: K973546 · Decision Nov 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    66
    Review Days
    50

    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
    KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K Number
    K973546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    September 18, 1997
    Decision Date
    November 7, 1997
    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 Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    K961977 KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →