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Reshape Lifesciences

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2024-05-16
TypeNumberDevice NameCodeDateActions
510(k) K241039 ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)KNT2024-05-16 View
510(k) K230131 ReShape Calibration TubesKNT2023-02-15 View
510(k) K221898 Gastrointestinal Boundary Identifier (GIBI HD)KNT2022-07-28 View
510(k) K220455 Lap-Band System Calibration TubeKNT2022-06-07 View