Home / 510(k) Clearances / K163272

510(k) K163272

AXIOS Stent and Electrocautery Enhanced Delivery System by Boston Scientific Corporation — Product Code PCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2017
Date Received
November 21, 2016
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 Boston Scientific Corporation

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K252529 — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M00681 (October 30, 2025)
  • K252547 — TheraSphere 360™ Y-90 Management Platform (October 28, 2025)
  • K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps (September 26, 2025)
  • K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure (September 24, 2025)
  • K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit (September 12, 2025)
  • K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID L (July 9, 2025)
  • K250310 — VIKING™ Fixed Curve Diagnostic Catheter (June 27, 2025)

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)
  • 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)