510(k) K230131

ReShape Calibration Tubes by Reshape Lifesciences — Product Code KNT

K230131 is an FDA 510(k) premarket notification submitted by Reshape Lifesciences for the device "ReShape Calibration Tubes". The FDA issued a decision of Substantially Equivalent on February 15, 2023. 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.