510(k) K231877

NavaClick Injection System by Lineage Biomedical, Inc. — Product Code FMF

K231877 is an FDA 510(k) premarket notification submitted by Lineage Biomedical, Inc. for the device "NavaClick Injection System". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.