# K010068: Rusch Polyflex Stent for the Esophagus with Introducer System

- Pathway: 510(k) (Abbreviated)
- Applicant: Rusch Intl.
- Decided: Feb 8, 2001 after 31 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K172813: Esophageal Stent System (2018), 3 descendants of its own
- K211960: Agile Esophageal OTW Stent System (2021), 2 descendants of its own

## Recalls of this device
- Apr 16, 2003 · Not classified · Z-0818-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0820-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0824-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0819-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0821-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0822-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0823-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0825-03: Radiopaque marker bands may not be visible under fluoroscopy
- Apr 16, 2003 · Not classified · Z-0826-03: Radiopaque marker bands may not be visible under fluoroscopy

Source page: https://510kreport.com/device/K010068
Methodology: https://510kreport.com/methodology