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..
List of System, Surgical, Computer Controlled Instrument devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Surgical, Computer Controlled Instrument devices (product code NAY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →