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

    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

    K Number: K070939 · Decision Jun 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    4
    Review Days
    58

    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
    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
    K Number
    K070939
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast Manufacturing Us, LLC
    Date Received
    April 4, 2007
    Decision Date
    June 1, 2007
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    Similar 510(k) Clearances

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

    BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

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

    Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

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

    Self-Cath Closed System

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

    AMSELF CLOSED CATHETERIZATION SYSTEM

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

    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

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

    AMSURE URETHRAL CATHETERIZATION TRAY

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

    Other Clearances by Coloplast Manufacturing Us, LLC

    K Number Device Name
    K100878 SELF CATH CATHETER
    K093112 DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
    K082640 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM