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Tech / Robot / FDA

EndoRobotics: Endoscopic Surgery Robot Gains FDA Approval

Dong-A Ilbo | Updated 2025.11.17
"Endorobotics possesses world-class technology based on extensive research by medical professionals and robotics technology."

In the early 19th century, doctors used candles and mirrors to look inside the human body. With the introduction of fiber optic technology in the 1950s, endoscopes finally became established as diagnostic tools, and the advent of laparoscopic surgery in the 1980s ushered in the era of minimally invasive surgery. The idea of performing surgery without making large incisions in the skin was revolutionary at the time. Forty years later, medical technology is once again poised for a leap forward, with robots taking center stage.

Kim Byung-gon, CEO of Endorobotics / Source=IT Donga

The medical robotics startup Endorobotics is gaining attention for developing key technologies that could change the paradigm of endoscopic surgery. This technology, which began in the mechanical engineering lab at Korea University, is now knocking on the doors of the global medical market. It is the first in Korea to obtain approval from the U.S. Food and Drug Administration (FDA) in the field of endoscopic surgery robots. CEO Kim Byung-gon shared Endorobotics' growth strategy and goals.

Decision to Found the Company with Support from Korea University Professors

Endorobotics was co-founded in 2019 by CEO Kim Byung-gon and Professor Hong Dae-hee of the Department of Mechanical Engineering at Korea University. The company name combines "Endoscope," meaning endoscope, and "Robotics," signifying robotic technology, which intuitively represents Endorobotics' main field of developing endoscopic surgery robots.

CEO Kim Byung-gon, who majored in mechanical engineering at Korea University, did not initially intend to start a business. While focusing on research for his dissertation on endoscopic surgery robots before graduating with a Ph.D. in engineering, he planned to join a large robotics company. Even when he received feedback that the robotic item he researched for his dissertation was suitable for commercialization in hospitals, he initially considered only technology transfer. However, with the encouragement and full support of his advisor, Professor Hong Dae-hee, and the faculty of Korea University's College of Medicine, he ultimately decided to start the company.

CEO Kim Byung-gon founded Endorobotics just a month after graduating from graduate school in 2019. The startup item was the endoscopic surgery robot he researched for his dissertation. Instead of creating a single endoscopic robot system with all functions, he decided to develop a detachable robotic solution compatible with existing endoscopic treatment devices. CEO Kim stated, "If we make an integrated endoscopic robot including the scope, we can achieve a more optimized design. However, we would have to compete with existing endoscopes, which would reduce accessibility," adding, "Endoscopes are familiar medical devices that have been used for a long time. By utilizing existing endoscopes, we judged that we could lower market entry barriers while solving technical challenges."

Easy Endoscopic Surgery with a Single Robopera

Robopera is an advanced robotic platform for precise endoscopic surgery and is compatible with existing endoscopes / Source=Endorobotics

Endorobotics provides endoscopic treatment solutions that are compatible with existing endoscopic diagnostic and treatment devices. Representative products include ▲TraCloser™ ▲RollingStitch™ ▲EndoCubot™ ▲ROBOPERA™. TraCloser is an endoscopic detachable multi-joint traction robotic arm that can continuously perform dissection and closing of lesions. The endoscope-mounted suturing device RollingStitch also boasts excellent performance.

Among them, EndoCubot is a new solution for simulator-based endoscopic procedure training, capable of simulating the exact location of lesions in the stomach or colon, and providing an environment similar to the human body, including patient breathing and sneezing. Robopera, too, is an advanced robotic platform for precise endoscopic surgery, compatible with existing endoscopic treatment devices, and operates with an intuitive and efficient interface.

Robopera particularly differentiates itself by realizing completely non-invasive surgery. It accesses the body's interior for disease treatment and diagnosis without skin incisions or invasive manipulation, allowing for cost savings and rapid recovery. CEO Kim stated, "The core of Robopera is micro cable control technology. The human throat has a diameter of about 15mm, posing a constraint. We had to overcome the physical limitation of making forceps, cameras, and surgical tools all operate within that space," explaining, "Endorobotics overcame the limited degrees of freedom of existing endoscopes through flexible cables that can rotate up to 720 degrees, significantly enhancing surgical accuracy and stability."

CEO Kim Byung-gon emphasizes that Robopera captures both technological innovation and practicality / Source=IT Donga

Another strength of Robopera is its practicality. While the existing Da Vinci surgical robot revolutionized the medical industry, its large size required changes to the operating room structure, and costs rose accordingly. Robopera is different. As a compatible detachable device, attaching the robotic arm to a diagnostic endoscope transforms it into a surgical robot, and after surgery, it reverts to a diagnostic endoscope. This makes it more attractive in the medical industry. CEO Kim stated, "Our technology can be introduced to gastroenterology departments worldwide without significant changes. Since it is compatible with existing endoscopic treatment devices, the burden of adoption is low."

FDA Approval This Year... Through Proprietary Technology and Strategic Approach

Endorobotics has steadily grown since its founding. By 2021, it had established its business foundation, and by focusing on product commercialization from 2022, it secured KRW 10 billion in funding through Series B investment, in addition to obtaining medical device quality management GMP certification. In 2024, it achieved results by establishing cooperative relationships with global medical companies, as it was highlighted at the world's largest medical academic conference, "DDW (Digestive Disease Week) 2024," and the global endoscopy forum "ENDO (World Congress of GI Endoscopy) 2024."

CEO Kim stated, "DDW 2024 was a famous event held in the United States. For early startups, it is common to use a single booth to gauge market reactions. Endorobotics boldly secured four booths, participating at the level of a global mid-sized company. This was because, during a preliminary visit to 'DDW 2023,' startups operating only one booth did not receive much attention. The result was successful. At that time, global medical companies showed great interest, leading to substantial cooperation."

Live clinical demonstration with Robopera at the global online conference 'Endoscopy On Air 2025' / Source=Endorobotics

At ENDO 2024, Endorobotics also made a bold move by releasing a live video of surgery using Robopera. Although the surgery was performed by a doctor experienced with Robopera, the bold display of new medical technology garnered a strong response. It didn't end there. An Indian doctor who encountered Robopera for the first time that year repeatedly exclaimed "So easy" during a clinical surgery the next day, even attributing the ease to the equipment rather than his own skills. This was a clear demonstration of Robopera's intuitive usability and practicality. CEO Kim recalled, "I remember feeling very proud internally at that time," with a smile.

Based on this proprietary technology, Robopera received the same "NAY" code as the Da Vinci surgical robot from the FDA in September this year. This code is not for simple auxiliary accessories but applies only to next-generation surgical robots that actively perform endoscopic interventional surgery. This means Robopera falls under the Class II medical device category, which requires high-level regulatory standards for safety, efficacy, and quality management according to FDA standards.

FDA approval is notoriously rigorous and complex, often taking years or resulting in rejection. In the case of Robopera, it passed from the submission of the FDA 510K application to review and approval in just 10 months through thorough pre-inquiries and preparation, making it even more significant.

Endorobotics strategically approached the FDA approval for Robopera / Source=IT Donga

Endorobotics' strategic approach to FDA approval for Robopera was effective. CEO Kim stated, "We knew the FDA approval process was not easy. We meticulously planned our strategy from the pre-inquiry stage and prepared various countermeasures in advance," adding, "When unexpected situations arose, we did not give up. We proposed alternative ways to prove our case and responded flexibly." He continued, "We thought from the FDA's perspective to create responses or situations that would satisfy them. By solving each issue, we achieved a good result."

Following FDA approval, Robopera is also undergoing the European CE (Conformité Européenne) certification process. CE is a legally required certification for the free sale and distribution of medical devices in the European Union market. Through this, Endorobotics aims to enhance its credibility in the global market. The company plans to accelerate its global expansion strategy with Series C funding within the year.

Confidence in Setting the Global Standard for Endoscopic Surgery

The growth of Endorobotics has been significantly supported by the Seoul Hongneung Small and Medium Business Innovation Zone (hereafter Hongneung Zone). Since being designated as a research institute company by the Ministry of Science and ICT's Research and Development Zone Promotion Foundation in 2021, Endorobotics has grown with various supports, including the Small and Medium Business Innovation Zone Development Project and Technology Transfer Commercialization (R&BD). From Series A investment attraction through matching with the Hongneung Advanced Science and Technology Commercialization Fund No. 1 to participation in IPO consulting programs, preliminary technology evaluation support, and selection as a Post-TIPS company, it has strengthened its technological competitiveness assessment and listing response capabilities.

CEO Kim expressed satisfaction, stating, "We received a lot of help from the Hongneung Zone in the early days of our startup. Particularly, the investment received through matching with the Hongneung Advanced Science and Technology Commercialization Fund No. 1 played a significant role in Endorobotics' growth. We are grateful."

Endorobotics expressed gratitude for the various supports received from the Ministry of Science and ICT, the Research and Development Zone Promotion Foundation, Seoul City, the Seoul Hongneung Small and Medium Business Innovation Zone, and Korea University Technology Holdings in the early days of its founding / Source=IT Donga

Going forward, Endorobotics' core task is production beyond technology development and regulatory approval. Having expanded to a new space in July this year, Endorobotics plans to add manufacturing facilities there. It intends to relocate its current manufacturing facility in Seongnam, Gyeonggi Province, to this location. CEO Kim explained, "For smooth communication, it is important for the people making, developing, and producing products to communicate organically. That's why we are bringing everyone together in one place."

Endorobotics has clear goals. CEO Kim envisions two futures. First, becoming a global company that provides products and services using high-tech while reducing the cost burden on patients and hospitals. Second, creating a happy corporate culture with high job satisfaction and a positive work environment.

CEO Kim stated, "When laparoscopic surgery was first introduced, it was considered groundbreaking, but now it has become the standard. I think Endorobotics' endoscopic surgery robot technology is similar to the early days of laparoscopic surgery. It is not a prediction but a certainty that this technology will become the standard in the global medical industry in the future."

The innovation initiated by CEO Kim Byung-gon's challenge is supported as a positive technological case that will be recorded in the global medical market and change human lives.

IT Donga Reporter Park Gui-im (luckyim@itdonga.com)
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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