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510(k) K223626

Niti-S Biliary Speed D Stent by Taewoong Medical Co., Ltd. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
May 26, 2023
Date Received
December 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
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)
  • 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 FGE

  • K253987 — BARE Wireguided Balloon Dilation Catheter (1235) (March 13, 2026)
  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)