# K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System - Pathway: 510(k) (Traditional) - Applicant: Boston Scientific - Decided: Apr 29, 2024 after 137 days - Product code: ESW (Prosthesis, Esophageal) - Device class: 2 - Regulation: 21 CFR 878.3610 - Recalls of this device: 22 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 9 generations back to K003173 (2001). 33 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 35 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K130004: Ultraflex Esophageal NG Stent System, Boston Scientific Corporation (2013) - K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730, Boston Scientific Corporation (2009) Summary page 6. ## Most influential descendants - K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (2026), 0 descendants of its own ## Recalls of this device - Aug 1, 2024 · Class II · Z-3270-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3267-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3266-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3278-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3272-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3286-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3282-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3279-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3280-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3277-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3281-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3285-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3271-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3275-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3283-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3284-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3265-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3276-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3274-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3269-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3273-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. - Aug 1, 2024 · Class II · Z-3268-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. ## Indications for use The Ultraflex Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistuIa. The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Source page: https://510kreport.com/device/K233939 Methodology: https://510kreport.com/methodology