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510(k) Data Aggregation
K Number
K040302Device Name
VERSAPOINT RESECTOSCOPIC SYSTEM
Manufacturer
GYNECARE, A DIV. OF ETHICON, INC.
Date Cleared
2004-03-09
(29 days)
Product Code
HIH
Regulation Number
884.1690Why 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
K013718Device 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
878.3300Why 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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