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., Asensus Surgical, Inc. and Intuitive Surgical.
FDA 510(k) Cleared System, Surgical, Computer Controlled Instrument Devices (Product Code NAY)
About Product Code NAY - Regulatory Context
510(k) Submission Activity
162 total 510(k) submissions under product code NAY since 2000, with 162 receiving FDA clearance (average review time: 140 days).
Submission volume has increased in recent years - 28 submissions in the last 24 months compared to 10 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for NAY submissions have been consistent, averaging 133 days recently vs 141 days historically.
NAY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →