# K163399: Tria Firm Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 22, 2017 after 199 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 K974541 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974541: Modified Ureteral Indwelling Catheter/Stent, Boston Scientific Corp (1998) Summary page 4.

## Most influential descendants
- K190603: Tria Firm Ureteral Stent (2019), 2 descendants of its own
- K250824: Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (2025), 0 descendants of its own
- K191609: Tria Soft Ureteral Stent (2019), 0 descendants of its own

## Indications for use
The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

Source page: https://510kreport.com/device/K163399
Methodology: https://510kreport.com/methodology