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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K244029

510(k) cleared

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

Endorobotics Co., Ltd. · Sep 24, 2025 · K244029

FDA cleared the ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) from Endorobotics Co., Ltd. on Sep 24, 2025 under K244029, a traditional 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 30, 2024. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Endorobotics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244029?

K244029 is the FDA 510(k) for ROBOPERA (ER-R-002); ROBOPERA (ER-R-003), submitted by Endorobotics Co., Ltd.. FDA's decision date was Sep 24, 2025, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)?

Endorobotics Co., Ltd., based in Seoul, is the applicant of record for K244029.

How long did the K244029 review take?

FDA received the submission on Dec 30, 2024 and issued its decision on Sep 24, 2025, 268 days later.

← All decisions in September 2025