WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K260126

510(k) cleared

Curajel Oral Gel

USpharma, Ltd. · Jun 15, 2026 · K260126

FDA cleared the Curajel Oral Gel from USpharma, Ltd. on Jun 15, 2026 under K260126, 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 Jan 15, 2026. The decision came 151 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 USpharma, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260126?

K260126 is the FDA 510(k) for Curajel Oral Gel, submitted by USpharma, Ltd.. FDA's decision date was Jun 15, 2026, under product code OLR (Oral Wound Dressing).

Who makes the Curajel Oral Gel?

USpharma, Ltd., based in Miami Lakes, FL, is the applicant of record for K260126.

How long did the K260126 review take?

FDA received the submission on Jan 15, 2026 and issued its decision on Jun 15, 2026, 151 days later.

← All decisions in June 2026