# K033368: Fossa Ureteral Open Lumen Stent

- Pathway: 510(k) (Special)
- Applicant: Fossa Medical, Inc.
- Decided: Nov 26, 2003 after 36 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K021602 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K031292: Modification to Fossa Ureteral Stone Sweeper, Fossa Medical, Inc. (2003)
- K021140: Fossa Expanding Double Pigtail Ureteral Stent, Fossa Industries, Inc. (2002)

## Most influential descendants
- K072293: Fossa Ureteral Open Stents (2008), 0 descendants of its own

## Indications for use
The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

Source page: https://510kreport.com/device/K033368
Methodology: https://510kreport.com/methodology