# K170362: Vortek Hydro-Coated Double Loop Ureteral Stents

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 15, 2017 after 282 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 K881744 (1988). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881744: Porges Ureteral Stent, Bivona Medical Technologies (1988) Summary page 4.
- K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent, International Regulatory Consultants (1998) Summary page 4.

## Most influential descendants
- K180057: Vortek Ureteral Double Loop Stent (2018), 2 descendants of its own
- K213186: NovoFlow Reinforced Ureteral Stent (2022), 0 descendants of its own
- K201436: Vortek Single Loop Ureteral Stent (2021), 0 descendants of its own
- K180469: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent (2018), 0 descendants of its own

## Indications for use
The double loop ureteral stents are used for: - drainage of the upper urinary tract over fistulas or ureteral obstacles - healing of the ureter

Source page: https://510kreport.com/device/K170362
Methodology: https://510kreport.com/methodology