# K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent

- Pathway: 510(k) (Special)
- Applicant: International Regulatory Consultants
- Decided: Oct 9, 1998 after 158 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.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170362: Vortek Hydro-Coated Double Loop Ureteral Stents (2017), 4 descendants of its own
- K180057: Vortek Ureteral Double Loop Stent (2018), 2 descendants of its own
- K013921: Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X (2002), 2 descendants of its own
- K213185: ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits (2022), 0 descendants of its own
- K213186: NovoFlow Reinforced Ureteral Stent (2022), 0 descendants of its own

## Indications for use
The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The “flush” ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

Source page: https://510kreport.com/device/K981591
Methodology: https://510kreport.com/methodology