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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 / K260218

510(k) cleared

LacertaMatrix

Lacerta Life Sciences · Feb 19, 2026 · K260218

FDA cleared the LacertaMatrix from Lacerta Life Sciences on Feb 19, 2026 under K260218, 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 Jan 23, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Lacerta Life Sciences has one other decision in the tracker over the last 12 months: K252673 (LacertaMatrix).

Questions & Answers

What did FDA clear under K260218?

K260218 is the FDA 510(k) for LacertaMatrix, submitted by Lacerta Life Sciences. FDA's decision date was Feb 19, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the LacertaMatrix?

Lacerta Life Sciences, based in Woodstock, GA, is the applicant of record for K260218.

How long did the K260218 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Feb 19, 2026, 27 days later.

← All decisions in February 2026