# K163068: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

- Pathway: 510(k) (Special)
- Applicant: Q Urological Corporation
- Decided: Dec 22, 2016 after 50 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: 1 generation back to K082805 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082805: Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX, Q Urological Corporation (2010) Summary page 5.

## Most influential descendants
- K172289: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (2017), 0 descendants of its own

## 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 endoscopes, 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/K163068
Methodology: https://510kreport.com/methodology