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510(k) Data Aggregation

    K Number
    K090271
    Device Name
    HYDROCOAT MESH
    Manufacturer
    PROMETHEAN SURGICAL DEVICES, INC.
    Date Cleared
    2010-01-14

    (344 days)

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

    PROMETHEAN SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydroCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse, and other fascial deficiencies that require support material.
    Device Description
    The HydroCoat Mesh is a polypropylene surgical mesh coated with polyurethane and intended for trauma and reconstructive surgical procedures involving soft tissues. The HydroCoat Mesh is fabricated from a knitted monofilament, medical-grade polypropylene fiber that links each porous window of the mesh, allowing for elasticity in both directions. The HydroCoat Mesh is available in various shapes and sizes for use in reinforcing soft tissues where weakness exists. The HydroCoat Mesh can be cut to most any shape or size for specific soft tissue reinforcement needs. The Promethean Surgical Devices HydroCoat Mesh is provided in various shapes such as rectangles, ovals, ellipticals and circles and will be provided in other shapes and sizes as needed for particular soft tissue reinforcement applications. The Promethean Surgical Devices HydroCoat Mesh is provided in sheets of various shapes and sizes as outlined in the table below: | Rectangular | Square | Elliptical | Oval | Round | Keyhole. | |-------------|-----------|------------|----------|-------------|-----------| | 12" x 12" | 12" x 12" | 12" x 10" | 12" x 9" | 8" diameter | 1.5" x 8" | | 12" x 10" | 10" x 10" | 10" x 8" | 10" x 7" | 6" diameter | 3" x 7" | | 10" x 8" | 8" x 8" | 8" x 6" | 8" x 5" | 5" diameter | | | 8" x 6" | 6" x 6" | 7" x 5" | 7" x 4" | 4" diameter | | | 7" x 5" | 4" x 4" | 6" x 4" | 6" x 3" | 3" diameter | | | 6" x 4" | | 5" x 3" | 5" x 2" | | | | 5" x 3" | | 4" x 2" | 4" x 1" | | | | 4" x 2" | | | | | | The thickness of the Promethean Surgical Devices HydroCoat Mesh ranges from 0.015" to 0.030" (0.38mm to 0.76mm) according to the region to be treated. The Promethean Surgical Devices HydroCoat Mesh is provided in flat sheets that contain micropores that range in size from 3mm2-to 5mm. The HydroCoat Mesh has an overall areal density of 1.1001 oz/yd2 (37.3 g/m2).
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