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510(k) K162717

Evolution Esophageal Stent System – Partially Covered by Cook Ireland, Ltd. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
September 29, 2016
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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  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K213946 — Compass BDS Biliary Stent (May 9, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)
  • DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System (November 20, 2019)
  • K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (November 16, 2018)
  • K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal B (July 6, 2018)
  • K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushin (March 9, 2018)
  • K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Bilia (February 27, 2018)

Other clearances for product code ESW

  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 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)