Cleared Special

Willow 18 Guidewire

K260130 · Arbor Endovascular, LLC · Neurology

Feb 2026

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K260130 is an FDA 510(k) clearance for the Willow 18 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 February 13, 2026, 28 days after receiving the submission on January 16, 2026. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K260130 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2026
Decision Date	February 13, 2026
Days to Decision	28 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF