510(k) K240761

Arisure® Closed Male Luer with Spike Adapter (YM060) by Yukon Medical, LLC — Product Code LHI

K240761 is an FDA 510(k) premarket notification submitted by Yukon Medical, LLC for the device "Arisure® Closed Male Luer with Spike Adapter (YM060)". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Yukon Medical, LLC has at least 10 other 510(k) clearances on record.