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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 / July 2026 / K253206

510(k) cleared

METICULY Patient-specific CMF solution

Meticuly Co., Ltd. · Jul 25, 2026 · K253206

FDA cleared the METICULY Patient-specific CMF solution from Meticuly Co., Ltd. on Jul 25, 2026 under K253206, a traditional 510(k). The device falls under product code JEY, Plate, Bone, regulated at 21 CFR 872.4760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 26, 2025. The decision came 302 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Meticuly Co., Ltd. has one other decision in the tracker over the last 12 months: K252958 (METICULY Patient-specific titanium mesh implant).

Questions & Answers

What did FDA clear under K253206?

K253206 is the FDA 510(k) for METICULY Patient-specific CMF solution, submitted by Meticuly Co., Ltd.. FDA's decision date was Jul 25, 2026, under product code JEY (Plate, Bone).

Who makes the METICULY Patient-specific CMF solution?

Meticuly Co., Ltd., based in Bangkok, is the applicant of record for K253206.

How long did the K253206 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jul 25, 2026, 302 days later.

← All decisions in July 2026

Sources