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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 / February 2026 / K260130

510(k) cleared

Willow 18 Guidewire

Arbor Endovascular, LLC · Feb 13, 2026 · K260130

FDA cleared the Willow 18 Guidewire from Arbor Endovascular, LLC on Feb 13, 2026 under K260130, a special 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 16, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Arbor Endovascular, LLC has 3 other decisions in the tracker over the last 12 months: K262424 (Willow 12 Guidewire), K260537 (Willow 24 Guidewire), K253168 (0.014 Willow Guidewire).

Questions & Answers

What did FDA clear under K260130?

K260130 is the FDA 510(k) for Willow 18 Guidewire, submitted by Arbor Endovascular, LLC. FDA's decision date was Feb 13, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Willow 18 Guidewire?

Arbor Endovascular, LLC, based in San Jose, CA, is the applicant of record for K260130.

How long did the K260130 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Feb 13, 2026, 28 days later.

← All decisions in February 2026

Sources