# K180053: Sof-Flex Ureteral Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 13, 2018 after 248 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151051: Universa Soft Ureteral Stents and Stent Sets, Cook Incorporated (2016) Summary page 4.
- K162104: C-Flex Ureteral Stent Set, Cook Incorporated (2017) Summary page 4.

## Indications for use
The Sof-Flex Ureteral Stent Set is intended for temporary internal drainage from the ureteropelvic junction to the bladder. Sof-Flex ureteral stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques. The 3 French stents are indicated for pediatric patients.

Source page: https://510kreport.com/device/K180053
Methodology: https://510kreport.com/methodology