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510(k) K252648

Niti-S SPAXUS Stent by Taewoong Medical Co., Ltd. — Product Code PCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
August 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pancreatic Stent, Covered, Metallic, Removable
Device Class
Class II
Regulation Number
876.5015
Review Panel
GU
Submission Type

To facilitate transmural endoscopic drainage of pancreatic pseudocysts

Other clearances by Taewoong Medical Co., Ltd.

  • 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)
  • 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 PCU

  • K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery System (September 7, 2022)
  • K203132 — AXIOS Stent and Electrocautery Enhanced Delivery System (April 15, 2021)
  • K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System (August 26, 2019)
  • K181905 — AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Deliver (March 25, 2019)
  • K163272 — AXIOS Stent and Electrocautery Enhanced Delivery System (February 18, 2017)
  • K153088 — AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Deli (December 11, 2015)
  • K152572 — AXIOS Stent and Delivery System (October 6, 2015)
  • K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System (August 5, 2015)
  • K140561 — AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVER (April 23, 2014)
  • DEN130007 — AXIOS STENT AND DELIVERY SYSTEM (December 18, 2013)