Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K131198
    Device Name
    TIPI OTC
    Manufacturer
    CONTIPI LTD.
    Date Cleared
    2013-08-27

    (123 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTIPI LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMPROVE BLADDER SUPPORT is an over-the-counter device intended for the temporary management of stress urinary incontinence (SUI) in women.
    Device Description
    The IMPROVE BLADDER SUPPORT device is a single use vaginal pessary, inserted into the vagina, by the user herself, using an applicator similar to a menstrual tampon applicator. The device comprises of a flexible silicone rubber core, covered with a non-woven mesh, and a removal string. Once inserted into the vagina, the core and cover of the device provides tension free mid-urethral support for the temporary management of stress urinary incontinence (SUI). After a maximum of 8 hours of use in a 24 hours period, the device should be removed from the vagina using its pull string and discarded.
    Ask a Question
    K Number
    K060526
    Device Name
    TIPI
    Manufacturer
    CONTIPI LTD.
    Date Cleared
    2006-06-09

    (102 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTIPI LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
    Device Description
    a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time. It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.
    Ask a Question

    Page 1 of 1