# K151051: Universa Soft Ureteral Stents and Stent Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 11, 2016 after 266 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903345 (1991). 6 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 18 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.
- K043193: Bard Inlayoptima Ureteral Stent with Suture, C.R. Bard, Inc. (2004) Summary page 4.

## Most influential descendants
- K161236: Universa Firm Ureteral Stents and Stent Sets (2017), 5 descendants of its own
- K213444: RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (2022), 2 descendants of its own
- K173734: RocaJJ Soft Stents (2018), 1 descendant of its own
- K162104: C-Flex Ureteral Stent Set (2017), 1 descendant of its own
- K251890: Disposable Ureteral Stents (2026), 0 descendants of its own

## Recalls of this device
- Jul 30, 2020 · Class II · Z-2971-2020: Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
- Jan 4, 2019 · Class II · Z-0978-2020: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

## Indications for use
Used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.

Source page: https://510kreport.com/device/K151051
Methodology: https://510kreport.com/methodology