# K955347: Ultraflex

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 16, 1996 after 87 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.
66 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032930: Ultraflex Esophageal NG Stent System (2003), 65 descendants of its own
- 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

Source page: https://510kreport.com/device/K955347
Methodology: https://510kreport.com/methodology