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510(k) K243619

Niti-S Esophageal Stent; Esophageal TTS Stent by Taewoong Medical Co., Ltd. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
November 22, 2024
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

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)
  • 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)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • 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

  • 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)
  • 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)