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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 / August 2026 / K262424

510(k) cleared

Willow 12 Guidewire

Arbor Endovascular, LLC · Aug 14, 2026 · K262424

FDA cleared the Willow 12 Guidewire from Arbor Endovascular, LLC on Aug 14, 2026 under K262424, 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 Jul 16, 2026. The decision came 29 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: K260537 (Willow 24 Guidewire), K260130 (Willow 18 Guidewire), K253168 (0.014 Willow Guidewire).

Questions & Answers

What did FDA clear under K262424?

K262424 is the FDA 510(k) for Willow 12 Guidewire, submitted by Arbor Endovascular, LLC. FDA's decision date was Aug 14, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Willow 12 Guidewire?

Arbor Endovascular, LLC, based in San Jose, CA, is the applicant of record for K262424.

How long did the K262424 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Aug 14, 2026, 29 days later.

← All decisions in August 2026

Sources