510(k) K242974

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters by Sophysa — Product Code JXG

K242974 is an FDA 510(k) premarket notification submitted by Sophysa for the device "External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Sophysa has at least 10 other 510(k) clearances on record.