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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 / April 2026 / K252251

510(k) cleared

EASYMADE-TI

CG Bio Co., Ltd. · Apr 9, 2026 · K252251

FDA cleared the EASYMADE-TI from CG Bio Co., Ltd. on Apr 9, 2026 under K252251, a traditional 510(k). The device falls under product code GXN, Plate, Cranioplasty, Preformed, Non-Alterable, regulated at 21 CFR 882.5330 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 18, 2025. The decision came 265 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: K253199 (CURASYS 2 (EMDN0003)).

Questions & Answers

What did FDA clear under K252251?

K252251 is the FDA 510(k) for EASYMADE-TI, submitted by CG Bio Co., Ltd.. FDA's decision date was Apr 9, 2026, under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable).

Who makes the EASYMADE-TI?

CG Bio Co., Ltd., based in Seoul, is the applicant of record for K252251.

How long did the K252251 review take?

FDA received the submission on Jul 18, 2025 and issued its decision on Apr 9, 2026, 265 days later.

← All decisions in April 2026

Sources