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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 / K253140

510(k) cleared

CollOvine Wound Powder

Ovigenex, LLC · Feb 10, 2026 · K253140

FDA cleared the CollOvine Wound Powder from Ovigenex, LLC on Feb 10, 2026 under K253140, 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 Sep 25, 2025. The decision came 138 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 Ovigenex, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253140?

K253140 is the FDA 510(k) for CollOvine Wound Powder, submitted by Ovigenex, LLC. FDA's decision date was Feb 10, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the CollOvine Wound Powder?

Ovigenex, LLC, based in Dominguez Hills, CA, is the applicant of record for K253140.

How long did the K253140 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Feb 10, 2026, 138 days later.

← All decisions in February 2026