Cleared Traditional

Bactiseal Catheters (K233445) - FDA 510(k) Clearance

Also marketed or referenced as:
Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233445 · Integra Lifesciences Production Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
90d
Days
Class 2
Risk

K233445 is an FDA 510(k) clearance for the Bactiseal Catheters. 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 January 17, 2024 after a review of 90 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K233445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2023
Decision Date January 17, 2024
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K233445.
Duet External Drainage and Monitoring System (EDMS)
K243676 · Medtronic Neurosurgery · Mar 2025
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K242003 · Aesculap, Inc. · Dec 2024
Borvo EVAC System (Ergo)
K241458 · Borvo Medical, Inc. · Aug 2024
Bactiseal EVD Catheter Sets
K233448 · Integra Lifesciences Production Corporation · Dec 2023
IRRAflow Active Fluid Exchange System (AFES)
K231664 · Irras USA, Inc. · Oct 2023
External Drainage System
K221694 · Jmed(Shenzhen) Technology Limited · Feb 2023