EndoRobotics Receives FDA Clearance for ROBOPERA™

SEOUL, KOREA — Sep 24, 2025 — EndoRobotics Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared ROBOPERA™, its endoscopic surgical robot, following a 510(k) premarket review.

The clearance includes the FDA's 'NAY' product code, a classification for robotic systems that actively perform endoscopic and laparoscopic interventions rather than passive accessories — the same code held by Intuitive Surgical's da Vinci system. EndoRobotics is the first Korean medical device company to receive an FDA clearance under this code.

The clearance reflects the FDA's determination that ROBOPERA™ is safe and effective for its intended use, clearing one of the higher regulatory bars in the global medical device industry.

Building on the clearance, EndoRobotics plans to begin its market entry and sales in the United States in the second half of the year.