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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 a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-07-23 under approval 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. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K251265.

When was Resilience Fully Covered Esophageal Stent System approved by the FDA?

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

What company makes Resilience Fully Covered Esophageal Stent System?

Resilience Fully Covered Esophageal Stent System is manufactured by Merit Medical Systems, Inc..

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.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation

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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