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FDA 510(k)

Resilience Fully Covered Esophageal Stent System

K-Number: K251265 · 2025-07-23

ApplicantMerit Medical Systems, Inc.
Decision Date2025-07-23
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Resilience Fully Covered Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K251265. 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 Resilience Fully Covered Esophageal Stent System?

Resilience Fully Covered Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K251265.

When did Resilience Fully Covered Esophageal Stent System receive FDA 510(k) clearance?

Resilience Fully Covered Esophageal Stent System received FDA 510(k) clearance on 2025-07-23, under 510(k) number K251265.

Who is the listed applicant for Resilience Fully Covered Esophageal Stent System?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resilience Fully Covered Esophageal Stent System?

The FDA product code for Resilience Fully Covered Esophageal 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.

NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

Other records listing Merit Medical Systems, Inc. as applicant

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.

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Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific CorporationK240522Esophageal 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.

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