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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 / K260244

510(k) cleared

Auryon Atherectomy System

Eximo Medical · Apr 10, 2026 · K260244

FDA cleared the Auryon Atherectomy System from Eximo Medical on Apr 10, 2026 under K260244, a traditional 510(k). The device falls under product code MCW, Catheter, Peripheral, Atherectomy, regulated at 21 CFR 870.4875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 27, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Eximo Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260244?

K260244 is the FDA 510(k) for Auryon Atherectomy System, submitted by Eximo Medical. FDA's decision date was Apr 10, 2026, under product code MCW (Catheter, Peripheral, Atherectomy).

Who makes the Auryon Atherectomy System?

Eximo Medical, based in Rehovot, is the applicant of record for K260244.

How long did the K260244 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Apr 10, 2026, 73 days later.

← All decisions in April 2026