# K180557: Greene Renal Transplant Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Nov 23, 2018 after 267 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K905289 (1991). 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)
- K961446: AQ Hydrophilic Stent, Cook Urological, Inc. (1996) Summary page 4.

## Indications for use
Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.

Source page: https://510kreport.com/device/K180557
Methodology: https://510kreport.com/methodology