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510(k) Data Aggregation
K Number
K023328Device Name
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
Date Cleared
2002-12-12
(69 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.
Device Description
The reinforced absorbable synthetic surgical mesh is a foam encased mesh. The foam component is a biocompatible elastomeric polymer that is bioabsorbable. This elastomer exhibits a high percent elongation, while possessing good tensile strength and good recovery characteristics. It has been found to be non-antigenic, non-pyrogenic, and elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the foam component provides wound support as well as increases the opportunity for bridging to occur due to its porosity. The mesh component is a woven polydioxanone mesh that is used to provide wound support during the healing process. It has been found to be non-antigenic, non-pyrogenic, and also elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the mesh component retains strength for a period of time long enough to permit sufficient healing, preventing wound dehiscence.
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