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510(k) Data Aggregation

    K Number
    K092203
    Device Name
    OMNISURE URETHRAL SLING, MODEL OTK52
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2009-08-12

    (21 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Omnisure™ Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    Omnisure™ Urethral Sling is a surgical mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device. The device is supplied sterile.
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    K Number
    K091180
    Device Name
    MINITAPE URETHRAL SLING
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2009-07-14

    (82 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Minitape® Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The subject device is a surgical mesh. The proprietary mesh is supplied along with ancillary tools for placement of the device (convenience kit). The kit consists of: Minitape Urethral Sling (mesh) intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency; Disposable needle introducers, optionally used to aid in placement of the Minitape mesh; Polydioxanone absorbable sutures (CP Medical; Portland, OR), used to secure the mesh in place; Polypropylene suture bolsters (Ethicon Inc.; Sommerville, NJ), optionally used to aid in tightening ("snugging") the mesh following surgical placement.
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    K Number
    K073647
    Device Name
    MINITAPE EXTRA URETHRAL SLING
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2008-03-03

    (68 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minitape* Extra Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency
    Device Description
    The subject device is a totally disposable mesh tape intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a monocomponent polypropylene tape with integral fixation zones on either side of a central sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.
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    K Number
    K073646
    Device Name
    MINITAPE URETHRAL SLING
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2008-02-25

    (61 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The subject device is a totally disposable tape mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.
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    K Number
    K053361
    Device Name
    MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2006-02-06

    (66 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
    Device Description
    Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
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    K Number
    K041632
    Device Name
    MINIMESH POLYPROPYLENE MESH
    Manufacturer
    MPATHY MEDICAL DEVICES, LTD.
    Date Cleared
    2004-11-17

    (154 days)

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

    MPATHY MEDICAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
    Device Description
    Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
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