# K072293: Fossa Ureteral Open Stents

- Pathway: 510(k) (Traditional)
- Applicant: Fossa Medical, Inc.
- Decided: Aug 6, 2008 after 356 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: 3 generations back to K021602 (2002). 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)
- K033368: Fossa Ureteral Open Lumen Stent, Fossa Medical, Inc. (2003) Summary page 1.
- K021140: Fossa Expanding Double Pigtail Ureteral Stent, Fossa Industries, Inc. (2002) Summary page 1.

## Indications for use
The OPEN-8 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/K072293
Methodology: https://510kreport.com/methodology