FDA 510(k)

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

K-Number: K243531 · 2025-08-08

ApplicantIntegra Lifesciences Production Corporation

Decision Date2025-08-08

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243531. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K243531.

When did Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology receive FDA 510(k) clearance?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243531.

Who is the listed applicant for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

The FDA 510(k) record lists Integra Lifesciences Production Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

The FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is JXG.

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NCT07655544Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard CathetersNOT_YET_RECRUITING

Other records listing Integra Lifesciences Production Corporation as applicant

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)K243552Codman 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)K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus Programmable Valves

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Related Devices (Code: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243552Codman 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)Integra Lifesciences Production Corporation K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.