# K021602: Fossa Ureteral Stone Sweeper

- Pathway: 510(k) (Traditional)
- Applicant: Fossa Industries, Inc.
- Decided: Jul 26, 2002 after 72 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.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Cook Double Pigtail Polyurethane Stent: named in the summary without a submission number
- (no number) Bard Double Pigtail Ureteral Stent: named in the summary without a submission number
- (no number) Surgitek Stone Basket: named in the summary without a submission number
- (no number) Boston Scientific (Van-Tec) Segura Basket: named in the summary without a submission number

## Most influential descendants
- K031292: Modification to Fossa Ureteral Stone Sweeper (2003), 2 descendants of its own
- 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/K021602
Methodology: https://510kreport.com/methodology