510(k) K222880

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) by Endolumik, Inc. — Product Code KNT

K222880 is an FDA 510(k) premarket notification submitted by Endolumik, Inc. for the device "Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)". The FDA issued a decision of Substantially Equivalent on March 3, 2023. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Endolumik, Inc. has at least 1 other 510(k) clearance on record.