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510(k) K213251

HANAROSTENT Esophagus Asymmetric (CCC) by M.I. Tech Co., Ltd. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2021
Date Received
September 30, 2021
Clearance Type
Special
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

Other clearances by M.I. Tech Co., Ltd.

  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (July 23, 2021)
  • K202973 — HANAROSTENT Benefit Biliary (NNN) (May 11, 2021)
  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (May 20, 2020)
  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
  • K183396 — HANAROSTENT FASTTM Biliary (NNN) (February 11, 2019)
  • K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (January 10, 2019)
  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K160893 — HANAROCare ReJu (July 27, 2016)

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)
  • K211706 — Esophageal TTS Stent (October 8, 2021)