# K984068: Flamingo Wallstent Esophageal Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Schneider (Europe) GmbH
- Decided: Jan 7, 1999 after 52 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- 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 K923119 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940396: Wallstent Esophageal Prosthesis (Double), Boston Scientific Scimed, Inc. (1994) Summary page 1.
- K923119: Wallstent Esophageal Prothesis, Schneider U.S. Stent Div. (1992) Summary page 1.

## Indications for use
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus, including cardia, due to a malignant process - palliative treatment of tracheo-esophageal fistulae due to a malignant process.

Source page: https://510kreport.com/device/K984068
Methodology: https://510kreport.com/methodology