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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 / July 2026 / K261658

510(k) cleared

LoFric Origo Pro Coudé

Wellspect AB · Jul 17, 2026 · K261658

FDA cleared the LoFric Origo Pro Coudé from Wellspect AB on Jul 17, 2026 under K261658, 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 May 19, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Wellspect AB has 2 other decisions in the tracker over the last 12 months: K260999 (LoFric Elle Pro), K250659 (LoFric Origo).

Questions & Answers

What did FDA clear under K261658?

K261658 is the FDA 510(k) for LoFric Origo Pro Coudé, submitted by Wellspect AB. FDA's decision date was Jul 17, 2026, under product code EZD (Catheter, Straight).

Who makes the LoFric Origo Pro Coudé?

Wellspect AB, based in Mölndal, is the applicant of record for K261658.

How long did the K261658 review take?

FDA received the submission on May 19, 2026 and issued its decision on Jul 17, 2026, 59 days later.

← All decisions in July 2026

Sources