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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 / April 2026 / K260999

510(k) cleared

LoFric Elle Pro

Wellspect AB · Apr 24, 2026 · K260999

FDA cleared the LoFric Elle Pro from Wellspect AB on Apr 24, 2026 under K260999, 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 Mar 26, 2026. The decision came 29 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: K261658 (LoFric Origo Pro Coudé), K250659 (LoFric Origo).

Questions & Answers

What did FDA clear under K260999?

K260999 is the FDA 510(k) for LoFric Elle Pro, submitted by Wellspect AB. FDA's decision date was Apr 24, 2026, under product code EZD (Catheter, Straight).

Who makes the LoFric Elle Pro?

Wellspect AB, based in Mölndal, is the applicant of record for K260999.

How long did the K260999 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Apr 24, 2026, 29 days later.

← All decisions in April 2026

Sources