# K081773: OSV II

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences Implants S.A.
- Decided: Nov 6, 2008 after 136 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: 2 generations back to K913636 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971799: Precision Flow Osv II, Elekta Implants, SA (1998). Our reading of the summary gave K911799, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OSV II”.

## Most influential descendants
- K092395: Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System (2009), 1 descendant of its own
- K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models (2015), 0 descendants of its own

## Indications for use
The OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Source page: https://510kreport.com/device/K081773
Methodology: https://510kreport.com/methodology