A Korean AI kidney-stone surgery robot clears the FDA

Roen Surgical, based in Daejeon, has announced that its kidney-stone surgery robot Zamenix™ P received 510(k) clearance from the US Food and Drug Administration as a Class II device. The company says it is the first FDA clearance for an AI-based robot that drives a flexible ureteroscope.

The device performs retrograde intrarenal surgery: instead of cutting, it passes a steerable flexible endoscope up the urethra and ureter into the kidney to break up and remove stones. Its software synchronises movement with the patient’s breathing, assists in judging stone size, and automates the approach of the laser fibre — the work that otherwise depends on a surgeon holding a scope steady against a moving target.

Zamenix has been installed at 20 hospitals in South Korea and one abroad, and 232 patients were enrolled in its multi-centre clinical trial. Korean regulators approved its use in clinical practice in May 2026. Chief executive Kwon Dong-soo said the Class II clearance shows the device met world-class regulatory standards.

Clearance is permission to sell, not evidence of better outcomes. The FDA’s public 510(k) database did not yet carry the record when this was written, which is normal administrative lag; the account here rests on the company’s own announcement as reported in Korean trade press.