Chemence Medical Gets 510(k) Clearance for Overhauled Skin-Closure System
The FDA has granted Chemence Medical 510(k) clearance for its redesigned Exofin fusion skin- closure device.
The product uses a self-adhering flexible mesh strip along with a fast-curing topical adhesive, 2-octyl cyanoacrylate, to close off incisions while providing a microbial barrier against infection.
The company said it redesigned the system by reshaping the mesh strip and relocating its initiator chemical, addressing common complaints in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Since its revamp, Chemence said it has heard of almost no negative patient outcomes.