Cleared Special

K202522 - Synchro SELECT Guidewire

K202522 is the FDA 510(k) clearance for Synchro SELECT Guidewire by Stryker Neurovascular. It is a Class 2 Neurology device (product code MOF) cleared through the Special 510(k) pathway after a 24-day FDA review.

K202522 · Stryker Neurovascular · Neurology device
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Sep 2020
Decision
24d
Days
Class 2
Risk

K202522 is an FDA 510(k) clearance for the Synchro SELECT Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on September 25, 2020 after a review of 24 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 Stryker Neurovascular devices

Submission Details

510(k) Number K202522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date September 25, 2020
Days to Decision 24 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
124d faster than avg
Panel avg: 148d · This submission: 24d
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 38
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K202522.
Aristotle Colossus Guidewire
K222437 · Scientia Vascular, Inc. · Jan 2023
RADIFOCUS Torque Device
K220934 · Terumo Medical Products Hangzhou Co., Ltd. · Jun 2022
Columbus Guidewire
K200374 · Rapid Medical , Ltd. · Dec 2020
Traxcess 7 Mini Guidewire
K201487 · MicroVention, Inc. · Jul 2020
Traxcess 14 SELECT Guidewire
K200547 · MicroVention, Inc. · Apr 2020
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
K191714 · Asahi Intecc Co., Ltd. · Jul 2019