Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

Q: What is the product code of K233445?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.

FDA 510(k) K233445 · Integra Lifesciences Production Corporation

Substantially Equivalent

510(k) numberK233445

Submission

Device name: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Applicant: Integra Lifesciences Production Corporation
Mansfield, MA, US
Received: October 19, 2023
Decision date: January 17, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JXG – Shunt, Central Nervous System And Components
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5550
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code JXG

510(k)	Device	Applicant	Decision
K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional	Integra Lifesciences Production Corporation	06/23/2026SE
K251598	IntellidropJXG · Traditional	Brainspace, Inc.	12/10/2025SE
K250636	Sophy Mini Monopressure Valve (SM1)JXG · Traditional	Sophysa	11/28/2025SE
K252514	Evac-MriJXG · Traditional	Phasor Health, LLC	11/05/2025SESD
K243531	Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional	Integra Lifesciences Production Corporation	08/08/2025SE
K243552	Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional	Integra Lifesciences Production Corporation	08/06/2025SE
K242974	External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional	Sophysa	06/20/2025SE
K243205	EvacJXG · Traditional	Phasor Health, LLC	06/03/2025SE
K243676	Duet External Drainage and Monitoring System (EDMS)JXG · Traditional	Medtronic Neurosurgery	03/10/2025SE
K242003	XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional	Aesculap, Inc.	12/16/2024SE

More from Aesculap, Inc.

510(k)	Device	Decision
K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional	06/23/2026SE
K243531	Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional	08/08/2025SE
K243552	Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional	08/06/2025SE
K232890	CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional	02/04/2024SE
K233448	Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG · Traditional	12/19/2023SE
K223330	Certas Plus Programmable ValvesJXG · Traditional	02/01/2023SE
K221840	Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG · Traditional	10/14/2022SE
K210993	CereLink ICP MonitorGWM · Special	04/30/2021SE

Questions and answers

When was Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter cleared by the FDA?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445) received a 510(k) decision of Substantially Equivalent on January 17, 2024, 90 days after the submission was received.

What is the product code of K233445?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.