Mesh Suture’s Duramesh Gains 510(k) Clearance
Puerto Rico-based medical equipment supplier Mesh Suture has received 510(k) clearance from the FDA for its Duramesh suture device.
The polypropylene mesh suture is designed for surgical closure of soft tissues including muscles, fascia, tendons and ligaments. It is flattened at the tissue interface to resist surgical failure due to suture pull-through.
The combination mesh-suture device is designed to avoid a problem with conventional sutures with sharp leading edges that can cut through intact tissue, potentially leading to the formation of hernias and poor tendon function, the company said.
Duramesh previously earned a CE-mark for use in countries that accept the European certification.