510(k) K231664

IRRAflow Active Fluid Exchange System (AFES) by Irras USA, Inc. — Product Code JXG

K231664 is an FDA 510(k) premarket notification submitted by Irras USA, Inc. for the device "IRRAflow Active Fluid Exchange System (AFES)". The FDA issued a decision of Substantially Equivalent on October 19, 2023. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Irras USA, Inc. has at least 3 other 510(k) clearances on record.