The FDA granted Lumendi 510(k) clearance for its DiLumen Ik endolumenal interventional knife, a disposable device designed for use in endoscopic surgery.
Thrown away after a single use, the knife is a monopolar electrosurgical device used for cutting, dissecting and cauterizing tissue in the digestive tract during endoscopic procedures.
The product is also able to administer a submucosal injection as tissue dissection is taking place, to create a fluid cushion.
