# K013784: Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 8, 2002 after 267 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K090430: Backstop and Backstop Injector (2009), 0 descendants of its own

## Indications for use
The proposed device is intended to facilitate the passage of urine from the kidney to the bladder.

Source page: https://510kreport.com/device/K013784
Methodology: https://510kreport.com/methodology