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510(k) K250663

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent by Taewoong Medical Co., Ltd. — Product Code MUM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2025
Date Received
March 5, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Metallic, Expandable, Duodenal
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)
  • 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 MUM

  • K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (June 14, 2023)
  • K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Un (May 4, 2017)
  • K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-1 (March 29, 2011)
  • K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005650 (December 4, 2006)
  • K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS (April 3, 1998)