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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 / November 2025 / K253168

510(k) cleared

0.014 Willow Guidewire

Arbor Endovascular, LLC · Nov 26, 2025 · K253168

FDA cleared the 0.014 Willow Guidewire from Arbor Endovascular, LLC on Nov 26, 2025 under K253168, 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 Sep 26, 2025. The decision came 61 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), K260130 (Willow 18 Guidewire).

Questions & Answers

What did FDA clear under K253168?

K253168 is the FDA 510(k) for 0.014 Willow Guidewire, submitted by Arbor Endovascular, LLC. FDA's decision date was Nov 26, 2025, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the 0.014 Willow Guidewire?

Arbor Endovascular, LLC, based in San Jose, CA, is the applicant of record for K253168.

How long did the K253168 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Nov 26, 2025, 61 days later.

← All decisions in November 2025

Sources