WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System— 510(k) K261978

Clearance details

Device name as filed

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Applicant

Boston Scientific Corporation

Product code

Code ESW

Device class

Class 2

Regulation

21 CFR 878.3610

Advisory panel

General, Plastic Surgery

Date received

2026-06-12

Decision date

2026-07-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Marlboro, MA, US

• K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent2025-10-30
• K253327 — HANAROSTENT Esophagus Upper (CCC)2025-10-30
• K251265 — Resilience Fully Covered Esophageal Stent System2025-07-23
• K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System2024-04-29
• K233837 — Agile Esophageal Stent System2024-04-04

• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
• K261488 — OBSIDIO Conformable Embolic2026-07-24
• K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24
• K262462 — TheraSphere 360 Y-90 Management Platform2026-07-24

Death

11

Injury

353

Malfunction

442

Total

806

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →