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510(k) Data Aggregation

    K Number
    K211132
    Device Name
    ARISTE AB Mesh
    Manufacturer
    Date Cleared
    2022-03-18

    (336 days)

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

    Ariste Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ARISTE AB Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The non-absorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surqical implantation. ARISTE AB Mesh is intended for single patient one-time use only.
    Device Description
    ARISTE AB Mesh is a non-resorbable sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The mesh is constructed of polypropylene fibers knitted together to form the mesh. The resulting structure is an implant which reinforces the tissue defect. The mesh is coated with a thiolene polymer. The coating acts as a carrier for antibiotic agents rifampin and minocycline in equal concentrations of approximately 171μg/cm² to help provide protection from bacterial colonization of the device during surgical implantation.
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