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510(k) K251265

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2025
Date Received
April 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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  • K241521 — Prelude Small O.D. Introducer Guide Wire (December 10, 2024)
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  • K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc (May 2, 2024)
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Other clearances for product code ESW

  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K240522 — Esophageal TTS Stent (March 22, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)
  • K211706 — Esophageal TTS Stent (October 8, 2021)