510(k) K221898

Gastrointestinal Boundary Identifier (GIBI HD) by Reshape Lifesciences — Product Code KNT

K221898 is an FDA 510(k) premarket notification submitted by Reshape Lifesciences for the device "Gastrointestinal Boundary Identifier (GIBI HD)". The FDA issued a decision of Substantially Equivalent on July 28, 2022. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Reshape Lifesciences has at least 3 other 510(k) clearances on record.