Cleared Special

0.014? Willow Guidewire

K253168 · Arbor Endovascular, LLC · Neurology

Nov 2025

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K253168 is an FDA 510(k) clearance for the 0.014? Willow Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Arbor Endovascular, LLC (San Jose, US). The FDA issued a Cleared decision on November 26, 2025, 61 days after receiving the submission on September 26, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K253168 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	November 26, 2025
Days to Decision	61 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF