# K013921: Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X

- Pathway: 510(k) (Traditional)
- Applicant: Porges S.A.
- Decided: Oct 17, 2002 after 324 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.
2 later devices descend from it; 2 cite 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)
- K881744: Porges Ureteral Stent, Bivona Medical Technologies (1988) Summary page 1.
- K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent, International Regulatory Consultants (1998) Summary page 1.

## Most influential descendants
- 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
- K180469: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent (2018), 0 descendants of its own

## Indications for use
Standard versions Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.9. periureteral tumour) Cicatrisation stent Reinforced versions Management of ureteral stenoses Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction syndrome Total enlargement of the diameter: stenoses over all or part of the ureter

Source page: https://510kreport.com/device/K013921
Methodology: https://510kreport.com/methodology