# K082805: Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Q Urological Corporation
- Decided: Jan 20, 2010 after 483 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Double Pigtail Ureteral Stent (Cook Urological): named in the summary without a submission number
- (no number) Sof-Flex Pediatric (Applied Medical Resource): named in the summary without a submission number
- (no number) PANAM…: named in the summary without a submission number
- (no number) Silhouette Pediatric Ureteral Stent: named in the summary without a submission number
- (no number) Aquasilque Ureteral Stent: named in the summary without a submission number

## Most influential descendants
- K163068: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (2016), 1 descendant of its own
- K172289: pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (2017), 0 descendants of its own

## Indications for use
pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary intrarenal urinary drainage from the kidney to the bladder and stenting of the ureter in a pediatric patient no less than 2 years old and not more than 12 years old. The stent may be placed endoscopically, percutaneously or using open surgical techniques. The stent should not be implanted for more than 30 days. This device is not intended as a permanent indwelling device.

Source page: https://510kreport.com/device/K082805
Methodology: https://510kreport.com/methodology