Cleared Traditional

Resilience Fully Covered Esophageal Stent System

K251265 · Merit Medical Systems, Inc. · Gastroenterology & Urology
Jul 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251265 is an FDA 510(k) clearance for the Resilience Fully Covered Esophageal Stent System, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 23, 2025, 90 days after receiving the submission on April 24, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K251265 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2025
Decision Date July 23, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code ESW — Prosthesis, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

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