# K201436: Vortek Single Loop Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Feb 25, 2021 after 269 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: 3 generations back to K881744 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 4.
- K180057: Vortek Ureteral Double Loop Stent, Coloplast Corp. (2018) Summary page 4.

## Indications for use
Surgical indication: The Vortek® Single Loop Ureteral Stent is intended for use in ureterostomy or vesical replacement in adult and pediatric (adolescents, children, and infants) patients requiring endourological procedure and /or short-term (less than 30 days) drainage of the upper urinary tract. Endoscopic indication: The Vortek® Single Loop Ureteral Stent is intended for short-term (less than 30 days) drainage of urine from the upper urinary tract over fistulas or ureteral obstacles in adult and pediatric (adolescents, children, and infants) patients.

Source page: https://510kreport.com/device/K201436
Methodology: https://510kreport.com/methodology