# K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Jun 30, 2003 after 129 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
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 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) Hood Esophageal Prosthesis: named in the summary without a submission number
- (no number) Boston Scientific Ultraflex: named in the summary without a submission number
- (no number) Boston Scientific Wall Stent: named in the summary without a submission number
- (no number) Cook, Inc. Esophageal Z-Stent: named in the summary without a submission number
- (no number) Wilson-Cook Esophageal Prosthesis Set: named in the summary without a submission number

## Most influential descendants
- K051621: Endoventions Alimaxx-E Esophageal Stent System (2005), 19 descendants of its own
- K080838: Alveolus Alimaxx-E Esophageal Stent System (2008), 17 descendants of its own
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- K180144: Agile Esophageal Stent System (2018), 3 descendants of its own

## Indications for use
Stenting : Esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures Esophageal-respiratory-fistula Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

Source page: https://510kreport.com/device/K030559
Methodology: https://510kreport.com/methodology