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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 / August 2026 / K253665

510(k) cleared

Vashe Plus Antimicrobial Solution

Urgo Medical North America, LLC · Aug 11, 2026 · K253665

FDA cleared the Vashe Plus Antimicrobial Solution from Urgo Medical North America, LLC on Aug 11, 2026 under K253665, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 21, 2025. The decision came 263 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 Urgo Medical North America, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253665?

K253665 is the FDA 510(k) for Vashe Plus Antimicrobial Solution, submitted by Urgo Medical North America, LLC. FDA's decision date was Aug 11, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Vashe Plus Antimicrobial Solution?

Urgo Medical North America, LLC, based in Fort Worth, TX, is the applicant of record for K253665.

How long did the K253665 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Aug 11, 2026, 263 days later.

← All decisions in August 2026