Class Class II

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531)

K243531 2025-08-08 Traditional
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Description

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology by Integra Lifesciences Production Corporation, an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243531
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeJXG
Regulation Number882.5550

Categories

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Predicate lineage for K243531

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Ba...Integra Lifesciences Production Cor...2024

Trace the full predicate network for K243531

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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