Endolumik Receives FDA Clearance for Flagship Product and Safer Technology Designation

Endolumik, an innovator in minimally-invasive surgical devices, today announced its fluorescence guided Gastric Calibration Tube has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology uses near infrared (NIR) light to allow surgeons to more clearly visualize surgical tools inside the stomach. The device was designated by the FDA as part of their Safer Technology Program, the first device ever approved through that program.

“Our mission is to provide surgeons with additional visual cues to succeed in the operating room.”
– Dr. Nova Szoka