Codman Libert?s? 1.5 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821761); Codman Libert?s? 1.9 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821762)

About This 510(k) Submission

K243552 is an FDA 510(k) clearance for the Codman Libert?s? 1.5 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821761); Codman Libert?s? 1.9 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821762), 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 6, 2025, 264 days after receiving the submission on November 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.