Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K190099 ↗

FDA Product Code

FJL

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

  Class II

  FDA 510(k) K191335 Active Cleared 6 Jun 2019

• Veloxion System

  Class II

  FDA 510(k) K230205 Active Cleared 24 Feb 2023

• Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

  Class II

  FDA 510(k) K180752 Active Cleared 25 Jul 2018

• Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

  Class II

  FDA 510(k) K190113 Active Cleared 24 Apr 2019

• Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

  Class II

  FDA 510(k) K191341 Active Cleared 13 Jun 2019

• Veloxion System

  Class II

  FDA 510(k) K162979 Active Cleared 24 Mar 2017