510(k) K243061

SonoStik Guide Wire Introducer by Sonostik, LLC — Product Code DYB

K243061 is an FDA 510(k) premarket notification submitted by Sonostik, LLC for the device "SonoStik Guide Wire Introducer". The FDA issued a decision of Substantially Equivalent on November 4, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Sonostik, LLC has at least 1 other 510(k) clearance on record.