Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B, CR40G

The Contour Curved Cutter Stapler is designed for cutting and stapling tissue during surgical procedures, particularly in colorectal applications. Its curved design accommodates the natural curvature and varying thickness of tissue in these areas, facilitating precise anastomoses—surgical connections between two structures, like parts of the intestine.

The Contour Curved Cutter Stapler and its reloads are explicitly intended for single-use only in an operating room setting. Storage must follow the manufacturer’s instructions to maintain integrity, though the data does not specify exact conditions—typically, this would include protection from contamination, extreme temperatures, and physical damage.

Four models are available: CS40B, CS40G, CR40B, and CR40G. The distinction between models (e.g., ‘B’ vs. ‘G’) likely relates to reload compatibility—specifically, whether they are designed for standard tissue (e.g., CS40B) or thicker tissue (e.g., CR40G). The ‘C’ prefix in CR models may indicate a specific curvature or application focus, though exact differences require consulting the manufacturer’s documentation.

The device has been authorized through FDA 510K and MDR (Medical Device Regulation) pathways. It is classified as a Class II medical device, which typically requires additional controls beyond general supervision due to its role in cutting and stapling tissue during surgery. Compliance with these regulations ensures safety and performance standards are met.