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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 / July 2026 / K262045

510(k) cleared

Luja Soft

Coloplast A.S. · Jul 7, 2026 · K262045

FDA cleared the Luja Soft from Coloplast A.S. on Jul 7, 2026 under K262045, a special 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 17, 2026. The decision came 20 days later, inside the 90 FDA-day goal for a 510(k).

Coloplast A.S. has one other decision in the tracker over the last 12 months: K252140 (Heylo System).

Questions & Answers

What did FDA clear under K262045?

K262045 is the FDA 510(k) for Luja Soft, submitted by Coloplast A.S.. FDA's decision date was Jul 7, 2026, under product code EZD (Catheter, Straight).

Who makes the Luja Soft?

Coloplast A.S., based in Minneapolis, MN, is the applicant of record for K262045.

How long did the K262045 review take?

FDA received the submission on Jun 17, 2026 and issued its decision on Jul 7, 2026, 20 days later.

← All decisions in July 2026