# K040201: Modification to Burr Hole Valve and Shunt System

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences Implants S.A.
- Decided: Feb 26, 2004 after 28 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970578 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970578: Radionics Burr Hole Valve, Radionics, Inc. (1997) Summary page 1.
- (no number) Burr Hole and Shunt System: named in the summary without a submission number

## Indications for use
The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.

Source page: https://510kreport.com/device/K040201
Methodology: https://510kreport.com/methodology