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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 / December 2025 / K250864

510(k) cleared

MatriDerm pluS+ Bi-Layer

Medskin Solutions Dr. Suwelack AG · Dec 19, 2025 · K250864

FDA cleared the MatriDerm pluS+ Bi-Layer from Medskin Solutions Dr. Suwelack AG on Dec 19, 2025 under K250864, 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 Mar 21, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medskin Solutions Dr. Suwelack AG has one other decision in the tracker over the last 12 months: K261224 (MatriDerm).

Questions & Answers

What did FDA clear under K250864?

K250864 is the FDA 510(k) for MatriDerm pluS+ Bi-Layer, submitted by Medskin Solutions Dr. Suwelack AG. FDA's decision date was Dec 19, 2025, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the MatriDerm pluS+ Bi-Layer?

Medskin Solutions Dr. Suwelack AG, based in Billerbeck, is the applicant of record for K250864.

How long did the K250864 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Dec 19, 2025, 273 days later.

← All decisions in December 2025

Sources