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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 / February 2026 / DEN250006

510(k) cleared

Amferia Wound Dressing

Amferia AB · Feb 6, 2026 · DEN250006

FDA cleared the Amferia Wound Dressing from Amferia AB on Feb 6, 2026 under DEN250006, a direct 510(k). The device falls under product code SHA, Solid Wound Dressing With Permanently Bound Antimicrobial Agent, regulated at 21 CFR 878.4013 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 3, 2025. The decision came 340 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 Amferia AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250006?

DEN250006 is the FDA 510(k) for Amferia Wound Dressing, submitted by Amferia AB. FDA's decision date was Feb 6, 2026, under product code SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent).

Who makes the Amferia Wound Dressing?

Amferia AB, based in Molndal, is the applicant of record for DEN250006.

How long did the DEN250006 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Feb 6, 2026, 340 days later.

← All decisions in February 2026