FDA Clears Roen Surgical's Zamenix Robot for Flexible Ureteroscopy of Kidney Stones

The US Food and Drug Administration has cleared Roen Surgical's Zamenix robotic system for flexible ureteroscopy, the kidney stone procedure in which a thin scope is passed up the urinary tract to reach and remove stones, the South Korean company announced on August 11, The Asia Business Daily reported.

The FDA's 510(k) database lists submission K253505 for the Zamenix P from Roen Surgical, Inc., of Daejeon, South Korea. The agency received the traditional 510(k) on October 31, 2025, and issued a decision of substantially equivalent on August 7, 2026. The device is classified under regulation 876.1500 with product code FGB, in the category of flexible and rigid ureteroscopes and accessories. The record shows the submission was not reviewed by a third party and that no predetermined change control plan was authorized.

The Asia Business Daily's English-language report renders the product name as "Jamenics"; the FDA record and the company's Korean materials use Zamenix.

What the robot does

According to the company's account as reported by The Asia Business Daily, the system lets a surgeon operate a flexible ureteroscope remotely and includes several assistive functions. A respiratory compensation function adjusts the endoscope's movement in time with the patient's breathing. A stone size guide is meant to help judge whether a stone fragment can pass. An automatic driving function automates repeated laser access.

The company also said the system works with existing endoscopes and laser equipment, so hospitals would not need to replace that equipment, and that remote operation is intended to reduce the operator's procedural fatigue.

Roen Surgical said the FDA review covered the reliability of the robot's control, the safety of accessories that contact the patient, sterilization, shelf life, biocompatibility, software and cybersecurity, electrical and mechanical safety, and preclinical testing. The company described the system as the first AI-based flexible ureteroscopic surgery robot to receive FDA clearance.

Track record in Korea and next steps

The robot was designated an innovative medical device in South Korea in 2021, and the company said it was evaluated in a multicenter clinical trial involving 232 patients. In May 2026, Korea's National Evidence-based Healthcare Collaborating Agency approved its clinical use as an innovative medical technology. Roen Surgical said the system is in use at 20 hospitals in Korea and one institution overseas.

"FDA Class II clearance signifies that the technology and safety of Jamenics have met the world's highest regulatory standards," Dongsoo Kwon, the company's chief executive, said, as quoted by The Asia Business Daily. "Starting with the U.S. market, we aim to prove our competitiveness in the global kidney stone treatment sector."

The company said it plans to use the US clearance as a basis for seeking other certifications, including a European CE mark, and to expand into Japan, the Middle East and Southeast Asia. It also said it intends to pursue collaborations with global device distributors and healthcare providers. Roen Surgical has not announced US pricing, a US launch date or any US hospital customers.