# K061876: Codman VPV System, Model 82-3192

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 16, 2006 after 105 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 K040943 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050739: Codman VPV System, Model 82-3192, Codman & Shurtleff, Inc. (2005) Summary page 1.
- K040943: Medtronic PS Medical Strata Valve, Medtronic Neurosurgery (2004) Summary page 2.

## Indications for use
The CODMAN® VPVTM System is designed for use only with CODMAN® HAKIM TM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to non-invasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and provides confirmation of the valve adjustment, without the need for radiographic imaging when an "Adjustment Complete" message is displayed.

Source page: https://510kreport.com/device/K061876
Methodology: https://510kreport.com/methodology