AXON SRL

AXON SRL specializes in percutaneous radio-frequency ablation devices. These include bipolar tumour-ablation probes, cooling tubing sets for probe insertion, and generator systems that control the ablation process. Their portfolio also includes disposable components like needles and connection sets, which are designed to work seamlessly with these systems to maintain sterility and compatibility during medical procedures.

AXON SRL is based in the United States. Since its devices fall under the US regulatory framework, they are subject to the requirements set by the FDA for medical devices in that jurisdiction. The company’s products are designed and manufactured in compliance with applicable US regulations.

AXON SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for all Class II devices, including those manufactured by AXON SRL, by assigning a unique identifier to each product.

AXON SRL’s devices are classified as Class II under the US regulatory system. This classification applies to most of their products, including ablation probes, cooling tubing sets, and generator systems. Class II devices are generally considered to pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.