FDA 510(k)

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

N.º K: K261978 · 2026-07-10

SolicitanteBoston Scientific Corporation

Fecha de decisión2026-07-10

Código de productoESW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261978. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261978.

When did WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System receive FDA 510(k) clearance?

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261978.

Who is the listed applicant for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

The FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is ESW.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Boston Scientific Corporation como solicitante

K262151SpaceOAR Flex™ System K261153LithoVue Elite Digital Flexible Ureteroscope System K261915Navigator™ Flex Ureteral Access Sheath Set K262165FARADRIVE™ Steerable Sheath (M004PF21M402)K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic

Ver todos los 167 dispositivos →

Dispositivos relacionados (Código: ESW)

K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation K240522Esophageal TTS StentTaewoong Medical

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.