Cleared Traditional

K243552 - Codman Libertís 1.5 mm EVD Catheter wit...

Also marketed or referenced as:
Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

K243552 is an FDA 510(k) clearance for Codman Libertís 1.5 mm EVD Catheter wit..., manufactured by Integra Lifesciences Production Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K243552 · Integra Lifesciences Production Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
264d
Days
Class 2
Risk

K243552 is an FDA 510(k) clearance for the Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology w.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on August 6, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Production Corporation devices

FDA 510(k) Submission Details - K243552

510(k) Number K243552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date August 06, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 148d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K243552.
Sophy Mini Monopressure Valve (SM1)
K250636 · Sophysa · Nov 2025
EVAC-MRI
K252514 · Phasor Health, LLC · Nov 2025
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
K243531 · Integra Lifesciences Production Corporation · Aug 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
K242974 · Sophysa · Jun 2025
EVAC
K243205 · Phasor Health, LLC · Jun 2025
Duet External Drainage and Monitoring System (EDMS)
K243676 · Medtronic Neurosurgery · Mar 2025