# K161236: Universa Firm Ureteral Stents and Stent Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 27, 2017 after 270 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: 5 generations back to K903345 (1991). 7 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 13 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.
- K043193: Bard Inlayoptima Ureteral Stent with Suture, C.R. Bard, Inc. (2004)

## Most influential descendants
- 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
- K251890: Disposable Ureteral Stents (2026), 0 descendants of its own
- K243830: Disposable ureteral stent (2025), 0 descendants of its own
- K232920: RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (2024), 0 descendants of its own
- K172017: Black Silicone Filiform Double Pigtail Stent Set (2018), 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.

## Indications for use
The Universa® Firm Ureteral Stents and Stent Sets are intended 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/K161236
Methodology: https://510kreport.com/methodology