# K162109: Kwart Retro-Inject Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 7, 2017 after 313 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
Longest line of descent: 1 generation back to K924608 (1994). 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)
- K010002: Contour Polaris Ureteral Stent, Boston Scientific Corp (2001) Summary page 4.
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 4.

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0960-2021: Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

## Indications for use
Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post- E.S.W.L.

Source page: https://510kreport.com/device/K162109
Methodology: https://510kreport.com/methodology