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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 / July 2026 / K260596

510(k) cleared

Collagen Wound Powder

Ventris Medical · Jul 2, 2026 · K260596

FDA cleared the Collagen Wound Powder from Ventris Medical on Jul 2, 2026 under K260596, 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 Feb 24, 2026. The decision came 128 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 Ventris Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260596?

K260596 is the FDA 510(k) for Collagen Wound Powder, submitted by Ventris Medical. FDA's decision date was Jul 2, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Collagen Wound Powder?

Ventris Medical, based in Newport Beach, CA, is the applicant of record for K260596.

How long did the K260596 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Jul 2, 2026, 128 days later.

← All decisions in July 2026