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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 / K244006

510(k) cleared

FG Bone Graft M

Full Golden Biotech Co., Ltd. · Sep 17, 2025 · K244006

FDA cleared the FG Bone Graft M from Full Golden Biotech Co., Ltd. on Sep 17, 2025 under K244006, a traditional 510(k). The device falls under product code LYC, Bone Grafting Material, Synthetic, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 26, 2024. The decision came 265 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 Full Golden Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244006?

K244006 is the FDA 510(k) for FG Bone Graft M, submitted by Full Golden Biotech Co., Ltd.. FDA's decision date was Sep 17, 2025, under product code LYC (Bone Grafting Material, Synthetic).

Who makes the FG Bone Graft M?

Full Golden Biotech Co., Ltd., based in Taichung City, is the applicant of record for K244006.

How long did the K244006 review take?

FDA received the submission on Dec 26, 2024 and issued its decision on Sep 17, 2025, 265 days later.

← All decisions in September 2025