ReShape Lifesciences Inc.

ReShape Lifesciences Inc. specializes in laparoscopic weight management devices. Its portfolio includes adjustable gastric bands, access port kits for fluid adjustments, calibration tubes for sizing the band, subcutaneous infusion ports, needles for accessing ports, and applicators for securing ports or tacks during surgery. These devices are designed for use in bariatric procedures to aid weight loss.

ReShape Lifesciences Inc. is headquartered in the United States. The company focuses on developing and manufacturing medical devices primarily for weight management and bariatric surgery applications.

ReShape Lifesciences Inc.’s devices are listed under the US Food and Drug Administration’s (FDA) Premarket Approval (PMA) and Unique Device Identification (UDI) programs. These registries ensure compliance with FDA requirements for medical devices, particularly for those classified as Class II or Class III.

ReShape Lifesciences Inc.’s devices are primarily classified as Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices, such as some gastric bands, are higher risk and require Premarket Approval (PMA) to demonstrate safety and performance before they can be marketed.

The devices manufactured by ReShape Lifesciences Inc. are intended for use in bariatric surgery to aid in weight loss. These include adjustable gastric bands that restrict stomach capacity, access ports for making fluid adjustments to the band, calibration tubes for proper sizing, and tools for surgical placement and maintenance, such as infusion ports and applicators. These devices work together to help patients manage obesity through surgical intervention.