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510(k) Data Aggregation

    K Number
    K040302
    Device Name
    VERSAPOINT RESECTOSCOPIC SYSTEM
    Manufacturer
    GYNECARE, A DIV. OF ETHICON, INC.
    Date Cleared
    2004-03-09

    (29 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNECARE, A DIV. OF ETHICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. - Excision of intrauterine myomas - - Excision of intrauterine polyps - - Lysis of intrauterine adhesions - - Incision of uterine septa - Endometrial ablation
    Device Description
    The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed to secure the distal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).
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    K Number
    K013718
    Device Name
    GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
    Manufacturer
    GYNECARE, A DIV. OF ETHICON, INC.
    Date Cleared
    2002-01-08

    (61 days)

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

    GYNECARE, A DIV. OF ETHICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
    Device Description
    GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. GYNEMESH PROLENE Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaption to various stresses encountered in the body.
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