FDA Product Code NAY: System, Surgical, Computer Controlled Instrument

Under FDA product code NAY, computer-controlled surgical instrument systems are cleared for use in minimally invasive and robotic-assisted procedures.

These systems integrate software-driven motion control with surgical instruments to enhance precision, reduce tremor, and enable complex procedures through small incisions. They are used in laparoscopic, thoracoscopic, and robotic surgery.

NAY devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Intuitive Surgical, Inc., Transenterix, Inc. and Intuitive Surgical.