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

    AMSELF CLOSED CATHETERIZATION SYSTEM

    K Number: K082831 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    17
    Review Days
    27

    Basic Information

    Device Name
    AMSELF CLOSED CATHETERIZATION SYSTEM
    K Number
    K082831
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMSINO INTERNATIONAL, INC.
    Date Received
    September 26, 2008
    Decision Date
    October 23, 2008
    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)

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    Other Clearances by AMSINO INTERNATIONAL, INC.

    K Number Device Name
    K101958 AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
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    K093773 AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
    K091306 AMSURE PVC INTERMITTENT CATHETER
    K091699 AMSURE HYDROPHILIC LATEX FOLEY CATHETER
    K070411 AMSURE NEBULIZER
    K061039 AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
    K050785 AMSINO ENDOTRACHEAL TUBE
    K051059 AMSURE 100% SILICONE FOLEY CATHETER
    K050656 AMSINO SUTURE REMOVAL KIT
    Search all 17 clearances from AMSINO INTERNATIONAL, INC. →