Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide

Q: What is the product code of K033850?

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) K033850 · Medtronic Neurosurgery

Substantially Equivalent

510(k) numberK033850

Submission

Device name: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide
Applicant: Medtronic Neurosurgery
Goleta, CA, US
Received: December 11, 2003
Decision date: January 13, 2004
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) statement 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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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
K243676	Duet External Drainage and Monitoring System (EDMS)JXG · Traditional	03/10/2025SE
K242034	Duet External Drainage and Monitoring System (EDMS)PCB · Special	10/24/2024SE
K212641	StrataMR II Valves and ShuntsJXG · Special	09/16/2021SE
K181622	StrataMR guider toolJXG · Traditional	10/01/2018SE
K161370	Durepair Dura Regeneration MatrixGXQ · Traditional	11/02/2016SE
K152700	StrataMR Valves and ShuntsJXG · Traditional	04/07/2016SE
K123524	Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional	02/13/2013SE
K110560	Medtronic Ares Antibiotic-Impregnated CatheterJXG · Traditional	11/18/2011SE
K091312	PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional	09/02/2009SE
K083076	Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836JXG · Special	11/20/2008SE

Questions and answers

When was Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide cleared by the FDA?

Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide (K033850) received a 510(k) decision of Substantially Equivalent on January 13, 2004, 33 days after the submission was received.

What is the product code of K033850?

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