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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 / June 2026 / K253199

510(k) cleared

CURASYS 2 (EMDN0003)

CG Bio Co., Ltd. · Jun 23, 2026 · K253199

FDA cleared the CURASYS 2 (EMDN0003) from CG Bio Co., Ltd. on Jun 23, 2026 under K253199, a traditional 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 26, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

CG Bio Co., Ltd. has one other decision in the tracker over the last 12 months: K252251 (EASYMADE-TI).

Questions & Answers

What did FDA clear under K253199?

K253199 is the FDA 510(k) for CURASYS 2 (EMDN0003), submitted by CG Bio Co., Ltd.. FDA's decision date was Jun 23, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the CURASYS 2 (EMDN0003)?

CG Bio Co., Ltd., based in Seoul, is the applicant of record for K253199.

How long did the K253199 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 23, 2026, 270 days later.

← All decisions in June 2026

Sources