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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 / K253974

510(k) cleared

Roosin Collagen Dressing

Roosin Medical Co., Ltd. · Jun 3, 2026 · K253974

FDA cleared the Roosin Collagen Dressing from Roosin Medical Co., Ltd. on Jun 3, 2026 under K253974, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 11, 2025. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roosin Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K254034 (Roosin Collagen Powder).

Questions & Answers

What did FDA clear under K253974?

K253974 is the FDA 510(k) for Roosin Collagen Dressing, submitted by Roosin Medical Co., Ltd.. FDA's decision date was Jun 3, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Roosin Collagen Dressing?

Roosin Medical Co., Ltd., based in Taizhou, is the applicant of record for K253974.

How long did the K253974 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Jun 3, 2026, 174 days later.

← All decisions in June 2026

Sources