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510(k) K221482

Esophageal TTS Stent by Taewoong Medical Co., Ltd. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2022
Date Received
May 23, 2022
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 Taewoong Medical Co., Ltd.

  • K252648 — Niti-S SPAXUS Stent (March 13, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (March 31, 2025)
  • K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (June 14, 2023)
  • K223626 — Niti-S Biliary Speed D Stent (May 26, 2023)
  • K223256 — Optimos™ Cystotome (April 5, 2023)
  • K221071 — Niti-S Biliary Slim M Stent (June 9, 2022)
  • K211706 — Esophageal TTS Stent (October 8, 2021)
  • K123205 — ESOPHAGEAL TTS STENT (October 9, 2013)

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)
  • 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)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)
  • K211706 — Esophageal TTS Stent (October 8, 2021)