# K091816: Ultraflex Esophageal NG Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 1, 2009 after 13 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
Longest line of descent: 2 generations back to K955347 (1996). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own
- K120983: Ultraflex Esophageal NG Stent System (2012), 3 descendants of its own
- K130004: Ultraflex Esophageal NG Stent System (2013), 2 descendants of its own
- K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (2024), 1 descendant of its own
- K141584: Ultraflex Tracheobronchial Covered Stent System (2014), 1 descendant of its own

## Recalls of this device
- Jul 15, 2010 · Not classified · Z-2322-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2321-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2323-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2319-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2316-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2320-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2318-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Jul 15, 2010 · Not classified · Z-2324-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment
- Jul 15, 2010 · Not classified · Z-2317-2010: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

## Indications for use
UltraflexTM Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. UltraflexTM Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

Source page: https://510kreport.com/device/K091816
Methodology: https://510kreport.com/methodology