Clearance Summary
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) received FDA 510(k) clearance under submission number K243552, sponsored by Integra Lifesciences Production Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-08-06.
- Submission: K243552
- Applicant / Sponsor: Integra Lifesciences Production Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 2025-08-06
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.