FDA 510(k)

Arisure® Closed Male Luer with Spike Adapter (YM060)

K-Number: K240761 · 2025-03-21

Decision Date2025-03-21

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Arisure® Closed Male Luer with Spike Adapter (YM060) is a medical device manufactured by Yukon Medical, LLC. It received FDA 510(k) clearance on 2025-03-21 under approval number K240761. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arisure® Closed Male Luer with Spike Adapter (YM060)?

Arisure® Closed Male Luer with Spike Adapter (YM060) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Yukon Medical, LLC. The 510(k) number is K240761.

When was Arisure® Closed Male Luer with Spike Adapter (YM060) approved by the FDA?

Arisure® Closed Male Luer with Spike Adapter (YM060) received FDA 510(k) clearance on 2025-03-21, under approval number K240761.

What company makes Arisure® Closed Male Luer with Spike Adapter (YM060)?

Arisure® Closed Male Luer with Spike Adapter (YM060) is manufactured by Yukon Medical, LLC.

What is the FDA product code for Arisure® Closed Male Luer with Spike Adapter (YM060)?

The FDA product code for Arisure® Closed Male Luer with Spike Adapter (YM060) is LHI.

Other Devices by Yukon Medical, LLC

K201422Arisure Closed System Drug Transfer Device (CSTD) K243486SmartSiteTM Vented Vial Access Device

Related Devices (Code: LHI)

K161800OnSite-IVPharmc, LLC K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. K162216GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. K171796Vial Adapter 15mmMedimop Medical Project , Ltd. K172884Arisure Closed Vial AdapterYukon Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.