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THE TAPE

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 / May 2026 / K261224

510(k) cleared

MatriDerm

Medskin Solutions Dr. Suwelack AG · May 14, 2026 · K261224

FDA cleared the MatriDerm from Medskin Solutions Dr. Suwelack AG on May 14, 2026 under K261224, a special 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 Apr 14, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Medskin Solutions Dr. Suwelack AG has one other decision in the tracker over the last 12 months: K250864 (MatriDerm pluS+ Bi-Layer).

Questions & Answers

What did FDA clear under K261224?

K261224 is the FDA 510(k) for MatriDerm, submitted by Medskin Solutions Dr. Suwelack AG. FDA's decision date was May 14, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the MatriDerm?

Medskin Solutions Dr. Suwelack AG, based in Billerbeck, is the applicant of record for K261224.

How long did the K261224 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on May 14, 2026, 30 days later.

← All decisions in May 2026

Sources