Cleared Special

K262424 - Willow 12 Guidewire

K262424 is an FDA 510(k) clearance for Willow 12 Guidewire, manufactured by Arbor Endovascular, LLC. The device is a Class 2 Neurology device with product code MOF cleared through the Special 510(k) pathway after a 29-day FDA review.

K262424 · Arbor Endovascular, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
29d
Days
Class 2
Risk

K262424 is an FDA 510(k) clearance for the Willow 12 Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Arbor Endovascular, LLC (San Jose, US). The FDA issued a Cleared decision on August 14, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arbor Endovascular, LLC devices

FDA 510(k) Submission Details - K262424

510(k) Number K262424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2026
Decision Date August 14, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MOF Device Classification - Class 2, Special Controls

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 43
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K262424.
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