510(k) K243531

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology by Integra Lifesciences Production Corporation — Product Code JXG

K243531 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology". The FDA issued a decision of Substantially Equivalent on August 8, 2025. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Lifesciences Production Corporation has at least 8 other 510(k) clearances on record.