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510(k) Data Aggregation

    K Number
    K063136
    Device Name
    NEEDLELESS SLING
    Manufacturer
    SPECIALITIES REMEEX INTERNATIONAL, S.L.
    Date Cleared
    2006-12-19

    (64 days)

    Product Code
    PAH
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITIES REMEEX INTERNATIONAL, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency
    Device Description
    The NEEDLELESS SLING is included in the sling techniques for the treatment of female stress urinary incontinence. This device is a vaginal sling that permits for the regulation of continence in the female incontinent patient. This system uses a mesh sling, placed under the urethra, that can be regulated during the intervention and just after it to achieve continence. The sling is passed through the endopelvic fascia, creating a fibrosis that supports the mid urethra as a limitation to its descending and thus providing continence.
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    K Number
    K062341
    Device Name
    MALE REMEEX SYSTEM
    Manufacturer
    SPECIALITIES REMEEX INTERNATIONAL, S.L.
    Date Cleared
    2006-11-02

    (84 days)

    Product Code
    OTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITIES REMEEX INTERNATIONAL, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence
    Device Description
    The MALE REMEEX SYSTEM (EXternal MEchanical REqulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.
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    K Number
    K033310
    Device Name
    REMEEX SYSTEM FOR URINARY INCONTINENCE
    Manufacturer
    SPECIALITIES REMEEX INTERNATIONAL, S.L.
    Date Cleared
    2004-01-15

    (93 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIALITIES REMEEX INTERNATIONAL, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.
    Device Description
    The REMEEX SYSTEM (EXternal MEchanical REgulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.
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