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510(k) K233318

AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) by Boston Scientific Corporation — Product Code KNS

K233318 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
September 29, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Boston Scientific Corporation

  • K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent Syst (July 10, 2026)
  • K260428 — RIVOS™ EUS Access Device (M00553900) (June 17, 2026)
  • K260100 — MOSES Raydar™ (May 18, 2026)
  • K260771 — TruSelect™ 2.6 Microcatheter (May 15, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)
  • K252529 — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M00681 (October 30, 2025)
  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K252547 — TheraSphere 360™ Y-90 Management Platform (October 28, 2025)

Other clearances for product code KNS

  • K260962 — Sphincterotome (May 21, 2026)
  • K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)

FDA data resources