# K081768: Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 23, 2008 after 186 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961923 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 2.
- K034068: Contour SE Microspheres, Boston Scientific Corp (2004) Summary page 2.
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 2.
- (no number) Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles marketed prior to 1976: named in the summary without a submission number

## Indications for use
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for embolization of the blood supply to symptomatic uterine fibroids.

Source page: https://510kreport.com/device/K081768
Methodology: https://510kreport.com/methodology