# K180469: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 6, 2018 after 258 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: 2 generations back to K881744 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013921: Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X, Porges S.A. (2002) Summary page 4.
- K170362: Vortek Hydro-Coated Double Loop Ureteral Stents, Coloplast Corp. (2017) Summary page 4.

## Indications for use
The Silicone Hydro-Coated 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/K180469
Methodology: https://510kreport.com/methodology