510(k) K241039

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) by Reshape Lifesciences — Product Code KNT

K241039 is an FDA 510(k) premarket notification submitted by Reshape Lifesciences for the device "ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)". The FDA issued a decision of Substantially Equivalent on May 16, 2024. 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.