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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 / April 2026 / K254191

510(k) cleared

IWD-Gel

InnovaCorium, Inc. · Apr 7, 2026 · K254191

FDA cleared the IWD-Gel from InnovaCorium, Inc. on Apr 7, 2026 under K254191, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 23, 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 InnovaCorium, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254191?

K254191 is the FDA 510(k) for IWD-Gel, submitted by InnovaCorium, Inc.. FDA's decision date was Apr 7, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the IWD-Gel?

InnovaCorium, Inc., based in Gainesville, FL, is the applicant of record for K254191.

How long did the K254191 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Apr 7, 2026, 105 days later.

← All decisions in April 2026