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510(k) Data Aggregation

    K Number
    K080442
    Device Name
    SERISCAFFOLD SURGICAL MESH
    Manufacturer
    SERICA TECHNOLOGIES, INC.
    Date Cleared
    2008-11-13

    (268 days)

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

    SERICA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SeriScaffold™ surgical mesh is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.
    Device Description
    SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.
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