Cleared Traditional

0.014? Willow Guidewire

K243756 · Arbor Endovascular, LLC · Neurology

Jul 2025

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K243756 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 July 17, 2025, 223 days after receiving the submission on December 6, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K243756 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	July 17, 2025
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF