SureAx-Guide
K-Number: K250203 · 2025-10-17
ApplicantSureax Medical, LLC
Decision Date2025-10-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SureAx-Guide is a medical device manufactured by Sureax Medical, LLC. It received FDA 510(k) clearance on 2025-10-17 under approval number K250203. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SureAx-Guide?
SureAx-Guide is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Sureax Medical, LLC. The 510(k) number is K250203.
When was SureAx-Guide approved by the FDA?
SureAx-Guide received FDA 510(k) clearance on 2025-10-17, under approval number K250203.
What company makes SureAx-Guide?
SureAx-Guide is manufactured by Sureax Medical, LLC.
What is the FDA product code for SureAx-Guide?
The FDA product code for SureAx-Guide is DQX.
Related Devices (Code: DQX)
K160785Worker GuidewireArgon Medical Devices, Inc.
K161702Endura guidewireVascular Solutions, Inc.
K160594MRWire Guide WireNano4imaging GmbH
K160643ENROUTE 0.014 GuidewireLake Region Medical
K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd.
K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.