Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is an FDA 510(k)-cleared medical device (K222880) manufactured by Endolumik, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 2, 2023. Regulation: 8.