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510(k) Data Aggregation

    K Number
    K120831
    Device Name
    ANCHORSURE
    Manufacturer
    NEOMEDIC INTERNATIONAL S.L.
    Date Cleared
    2012-10-12

    (207 days)

    Product Code
    PBQ
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMEDIC INTERNATIONAL S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anchorsure is indicated for attaching suture to ligaments of the pelvic floor
    Device Description
    Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.
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    K Number
    K103022
    Device Name
    KIM
    Manufacturer
    NEOMEDIC INTERNATIONAL S.L.
    Date Cleared
    2011-12-20

    (434 days)

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

    NEOMEDIC INTERNATIONAL S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.
    Device Description
    KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. KIM (Knotless Incontinence Mesh) is composed by a monofilament polypropylene mesh sling and two passers used to pass the sling through the obturator foramens. Polypropylene monofilament traction threads are fixed at each end of the mesh to facilitate the attachment of the passers to the mesh. The passers are used to deliver the sling via the trans-obturator "out-inside" approach. The traction threads are removed after placement of the sling. When placing the mesh, the sling can be adjusted by the surgeon to leave the mesh flat under the urethra, at the proper tension providing extra support to the urethra.
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    K Number
    K102815
    Device Name
    SURELIFT PROLAPSE SYSTEM
    Manufacturer
    NEOMEDIC INTERNATIONAL
    Date Cleared
    2011-07-07

    (282 days)

    Product Code
    OTP
    Regulation Number
    884.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMEDIC INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
    Device Description
    The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement. The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens. The mesh has six fixation points (two posterior fixation points and four arms): - Two posterior fixation points that are fixed to the sacrospinose ligaments. - Two middle arms that are passed through the arcus tendineus. - Two anterior arms that are passed through the anterior part of the obturator foramen. When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.
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