# K172017: Black Silicone Filiform Double Pigtail Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 26, 2018 after 266 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: 6 generations back to K903345 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161236: Universa Firm Ureteral Stents and Stent Sets, Cook Incorporated (2017) Summary page 4.

## Indications for use
This product is used for temporary internal drainage from the ureteropelvic junction to the bladder. They are not intended to remain indwelling more than twelve months.

Source page: https://510kreport.com/device/K172017
Methodology: https://510kreport.com/methodology