Lumendi Receives 510(k) Clearance for Endoscopic Accessory

The FDA gave Lumendi 510(k) clearance for its DiLumen C2 device, an endoscopic accessory used to ensure complete positioning of an endoscope in the large intestine.

The DiLumen C2 uses two 6mm diameter tool channels which accommodate two flexible articulating hand instruments.

The device also assists with optical visualization, endoscopic treatment and diagnosis, and has two balloons that create a stabilizing therapeutic zone inside the colon during procedures.