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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 / June 2026 / K260669

510(k) cleared

Endoform Dermal Template

Aroa Biosurgery , Ltd. · Jun 24, 2026 · K260669

FDA cleared the Endoform Dermal Template from Aroa Biosurgery , Ltd. on Jun 24, 2026 under K260669, 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 2, 2026. The decision came 114 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 Aroa Biosurgery , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260669?

K260669 is the FDA 510(k) for Endoform Dermal Template, submitted by Aroa Biosurgery , Ltd.. FDA's decision date was Jun 24, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Endoform Dermal Template?

Aroa Biosurgery , Ltd., based in Auckland, is the applicant of record for K260669.

How long did the K260669 review take?

FDA received the submission on Mar 2, 2026 and issued its decision on Jun 24, 2026, 114 days later.

← All decisions in June 2026