Codman Libert?s Shunt Catheter with Bactiseal and Endexo Technology

About This 510(k) Submission

K243531 is an FDA 510(k) clearance for the Codman Libert?s Shunt Catheter with Bactiseal and Endexo Technology, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on August 8, 2025, 267 days after receiving the submission on November 14, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.