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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 / October 2025 / K252001

510(k) cleared

Collagen Wound Dressing

Winner Medical Co., Ltd. · Oct 10, 2025 · K252001

FDA cleared the Collagen Wound Dressing from Winner Medical Co., Ltd. on Oct 10, 2025 under K252001, 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 Jun 27, 2025. The decision came 105 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 Winner Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252001?

K252001 is the FDA 510(k) for Collagen Wound Dressing, submitted by Winner Medical Co., Ltd.. FDA's decision date was Oct 10, 2025, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Collagen Wound Dressing?

Winner Medical Co., Ltd., based in Shenzhen, is the applicant of record for K252001.

How long did the K252001 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Oct 10, 2025, 105 days later.

← All decisions in October 2025