FDA 510(k) clearance · back to tracker

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Integra Lifesciences Production Corporation cleared K243531 on 2025-08-08, decision: substantially equivalent

K-number

K243531

Sponsor

Integra Lifesciences Production Corporation

Device

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-08-08

Product code

JXG

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.5550

Official FDA record

Open K243531on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.