# K031292: Modification to Fossa Ureteral Stone Sweeper

- Pathway: 510(k) (Special)
- Applicant: Fossa Medical, Inc.
- Decided: May 22, 2003 after 29 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 K021602 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021602: Fossa Ureteral Stone Sweeper, Fossa Industries, Inc. (2002)

## Most influential descendants
- K033368: Fossa Ureteral Open Lumen Stent (2003), 1 descendant of its own
- K072293: Fossa Ureteral Open Stents (2008), 0 descendants of its own

## Indications for use
The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.

Source page: https://510kreport.com/device/K031292
Methodology: https://510kreport.com/methodology