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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 / October 2025 / K252425

510(k) cleared

Silatrix Oral Gel

Sa3, LLC · Oct 23, 2025 · K252425

FDA cleared the Silatrix Oral Gel from Sa3, LLC on Oct 23, 2025 under K252425, a traditional 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 1, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sa3, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252425?

K252425 is the FDA 510(k) for Silatrix Oral Gel, submitted by Sa3, LLC. FDA's decision date was Oct 23, 2025, under product code OLR (Oral Wound Dressing).

Who makes the Silatrix Oral Gel?

Sa3, LLC, based in Los Angeles, CA, is the applicant of record for K252425.

How long did the K252425 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Oct 23, 2025, 83 days later.

← All decisions in October 2025