Atys Medical

Atys Medical specializes in basic surgical instruments, specifically models BASIC 1, BASIC 2, and BASIC 3. These devices are intended for general surgical procedures, providing essential tools for surgical teams in operating rooms.

Atys Medical is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governed by the FDA.

Atys Medical’s devices, including BASIC 1, BASIC 2, and BASIC 3, are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Atys Medical’s devices are supported by 510(k) clearances through the FDA’s regulatory pathway. The 510(k) process demonstrates that the devices are substantially equivalent to legally marketed predicate devices, ensuring they meet applicable safety and performance requirements before entering the market.