510(k) K231468

SCOUT MD Surgical Guidance System by Merit Medical System, Inc. — Product Code NEU

K231468 is an FDA 510(k) premarket notification submitted by Merit Medical System, Inc. for the device "SCOUT MD Surgical Guidance System". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Merit Medical System, Inc. has at least 4 other 510(k) clearances on record.