Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

Q: What is the product code of K153041?

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) K153041 · Integra LifeSciences Corporation

Substantially Equivalent

510(k) numberK153041

Submission

Device name: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Applicant: Integra LifeSciences Corporation
Planisboro, NJ, US
Received: October 19, 2015
Decision date: March 14, 2016
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

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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.

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K240493	CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional	07/11/2024SE
K230427	CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional	07/11/2023SE
K221835	CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional	08/22/2022SE
K221763	CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special	07/15/2022SE
K210128	INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional	10/08/2021SE
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Questions and answers

When was Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling cleared by the FDA?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (K153041) received a 510(k) decision of Substantially Equivalent on March 14, 2016, 147 days after the submission was received.

What is the product code of K153041?

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