Search Results

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the implant is achieved. The system instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.

This is a 510(k) summary for a surgical mesh device (K112386). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that the proposed changes described in the submission do not affect the materials, design, components, or technological features of the device, implying that no new performance studies were conducted for this specific submission to demonstrate compliance with new acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device (K083499) based on existing characteristics.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device