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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 / K251929

510(k) cleared

SilverCeuticals® Antimicrobial Wound Gel

Silverceuticals, Inc. · Jun 24, 2026 · K251929

FDA cleared the SilverCeuticals® Antimicrobial Wound Gel from Silverceuticals, Inc. on Jun 24, 2026 under K251929, 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 Jun 23, 2025. The decision came 366 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 Silverceuticals, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251929?

K251929 is the FDA 510(k) for SilverCeuticals® Antimicrobial Wound Gel, submitted by Silverceuticals, Inc.. FDA's decision date was Jun 24, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the SilverCeuticals® Antimicrobial Wound Gel?

Silverceuticals, Inc., based in Lindon, UT, is the applicant of record for K251929.

How long did the K251929 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Jun 24, 2026, 366 days later.

← All decisions in June 2026