Medwaves Incorporated

Medwaves Incorporated specializes in microwave coagulation and ablation systems. These include generators and antenna-probes of different sizes, such as small, medium, large, and mini probes. The devices are primarily used for tissue ablation, often in procedures like tumor treatment or other medical interventions requiring precise tissue destruction.

Medwaves Incorporated is based in the United States. The company’s headquarters and operations are located within the country, where it develops and manufactures its microwave ablation systems.

Medwaves Incorporated’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II medical devices in the US, which includes the company’s microwave coagulation and ablation systems. Listing in this registry indicates compliance with FDA requirements for these specific device types.

Medwaves Incorporated’s devices are classified as Class II medical devices under US regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as microwave ablation systems used in tissue coagulation and destruction procedures.