Cleared Special

Aristotle 14 Guidewire (K243938) - FDA 510(k) Clearance

Also marketed or referenced as:
Aristotle 18 Guidewire Aristotle 24 Guidewire Zoom Wire 14 Guidewire Aristotle Colossus Guidewire

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243938 · Scientia Vascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
102d
Days
Class 2
Risk

K243938 is an FDA 510(k) clearance for the Aristotle 14 Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on April 1, 2025 after a review of 102 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scientia Vascular, Inc. devices

Submission Details

510(k) Number K243938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date April 01, 2025
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 29
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K243938.
X-Wire Guidewire
K244061 · Imperative Care, Inc. · Aug 2025
0.014” Willow Guidewire
K243756 · Arbor Endovascular, LLC · Jul 2025
CHIKAI Nexus 014
K243383 · Asahi Intecc Co., Ltd. · Apr 2025
Synxess Neurovascular Guidewire
K240871 · Enlight Medical Technologies (Shenzhen) Co., Ltd. · Nov 2024
Drivewire 24 Guidewire
K233791 · Rapid Medical , Ltd. · Jul 2024
Aristotle 18 Guidewire
K231954 · Scientia Vascular, Inc. · Aug 2023