510(k) K251265

Resilience Fully Covered Esophageal Stent System by Merit Medical Systems, Inc. — Product Code ESW

K251265 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Resilience Fully Covered Esophageal Stent System". The FDA issued a decision of Substantially Equivalent on July 23, 2025. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.