K191341 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
(FDA 510(k) Clearance)

K191341 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags. This device is classified as a Resectoscope (Class II — Special Controls, product code FJL).

Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 13, 2019, 24 days after receiving the submission on May 20, 2019.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.