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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sureax Medical, LLC. It received FDA 510(k) clearance on 2025-10-17 under 510(k) 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. The listed applicant is Sureax Medical, LLC. The 510(k) number is K250203.

When did SureAx-Guide™ receive FDA 510(k) clearance?

SureAx-Guide™ received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250203.

Who is the listed applicant for SureAx-Guide™?

The FDA 510(k) record lists Sureax Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureAx-Guide™?

The FDA product code for SureAx-Guide™ is DQX.

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

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