# K032930: Ultraflex Esophageal NG Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 23, 2003 after 31 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955347 (1996). 1 ancestor in all.
65 later devices descend from it; 7 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955347: Ultraflex, Boston Scientific Corp (1996) Summary page 1.

## Most influential descendants
- K041648: Niti-S Stent & Introducer, Model Eoxxxx (2005), 27 descendants of its own
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- 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
- K080782: Niti-S Esophageal Stent (2009), 15 descendants of its own

## Recalls of this device
- May 17, 2010 · Not classified · Z-1858-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1864-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1860-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1865-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1863-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1872-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1871-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1868-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1862-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1867-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1866-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1870-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1869-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1873-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1861-2010: Suture related device failures during deployment and repositioning of the stent
- May 17, 2010 · Not classified · Z-1859-2010: Suture related device failures during deployment and repositioning of the stent

## Indications for use
The Ultraflex™ 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. The Covered Ultraflex™ Esophageal NG Stent System 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/K032930
Methodology: https://510kreport.com/methodology