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510(k) DEN130007

AXIOS STENT AND DELIVERY SYSTEM by Xlumena, Inc. — Product Code PCU

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 18, 2013
Date Received
February 19, 2013
Clearance Type
Post-NSE
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 Xlumena, Inc.

  • K140561 — AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVER (April 23, 2014)
  • K093279 — NAVIX ACCESS DEVICE (April 7, 2010)

Other clearances for product code PCU

  • K252648 — Niti-S SPAXUS Stent (March 13, 2026)
  • 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)