# K172289: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

- Pathway: 510(k) (Special)
- Applicant: Q Urological Corporation
- Decided: Oct 4, 2017 after 65 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 K082805 (2010). 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)
- K163068: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent, Q Urological Corporation (2016) Summary page 5.

## Indications for use
The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopic, percutaneous or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

Source page: https://510kreport.com/device/K172289
Methodology: https://510kreport.com/methodology