# K021140: Fossa Expanding Double Pigtail Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Fossa Industries, Inc.
- Decided: Jun 28, 2002 after 80 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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

## 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 Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.

Source page: https://510kreport.com/device/K021140
Methodology: https://510kreport.com/methodology