# K010002: Contour Polaris Ureteral Stent

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jan 22, 2001 after 20 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030503: Modification to Contour Polaris Ureteral Stent (2003), 1 descendant of its own
- K212868: JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (2022), 0 descendants of its own
- K162109: Kwart Retro-Inject Ureteral Stent (2017), 0 descendants of its own

## Recalls of this device
- May 10, 2006 · Not classified · Z-1238-06: Instructions on how to inject are not included in the package.

Source page: https://510kreport.com/device/K010002
Methodology: https://510kreport.com/methodology