510(k) K234145

ViSiGi 3D Gastric Sizing Tube by Boehringer Laboratories — Product Code KNT

K234145 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "ViSiGi 3D Gastric Sizing Tube". The FDA issued a decision of Substantially Equivalent on January 26, 2024. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Boehringer Laboratories has at least 10 other 510(k) clearances on record.