# K050739: Codman VPV System, Model 82-3192

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jul 18, 2005 after 119 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hakim Programmer & Transmitter: named in the summary without a submission number

## Most influential descendants
- K061876: Codman VPV System, Model 82-3192 (2006), 0 descendants of its own

## Indications for use
The system is designed for use only with CODMAN HAKIM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the CODMAN HAKIM Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.

Source page: https://510kreport.com/device/K050739
Methodology: https://510kreport.com/methodology