FDA 510(k)

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

K-Number: K261978 · 2026-07-10

Decision Date2026-07-10

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITING NCT01550575Patient Retrospective Outcomes (PRO)RECRUITING NCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITING NCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITING NCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITING NCT02928497Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationTERMINATED

Other records listing Boston Scientific Corporation as applicant

K262406EluPro Antibiotic-Eluting BioEnvelope PMA P150031Stimulator, electrical, implanted, for parkinsonian symptoms PMA P030017Stimulator, spinal-cord, totally implanted for pain relief PMA P190006Implanted electrical device intended for treatment of fecal incontinence PMA P180046Stimulator, electrical, implantable, for incontinence PMA P180011Stent, superficial femoral artery, drug-eluting

View all 251 devices →

Related Devices (Code: 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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.