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510(k) Data Aggregation
K Number
K211132Device Name
ARISTE AB Mesh
Manufacturer
Date Cleared
2022-03-18
(336 days)
Product Code
Regulation Number
878.3300Why 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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