510(k) K243676

Duet External Drainage and Monitoring System (EDMS) by Medtronic Neurosurgery — Product Code JXG

K243676 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "Duet External Drainage and Monitoring System (EDMS)". The FDA issued a decision of Substantially Equivalent on March 10, 2025. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.