Cleared Traditional

K190099 - Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
(FDA 510(k) Clearance)

K190099 · Corinth Medtech, Inc. · Gastroenterology & Urology

Mar 2019

Decision

52d

Days

Class 2

Risk

K190099 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, a Resectoscope (Class II — Special Controls, product code FJL), submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on March 15, 2019, 52 days after receiving the submission on January 22, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K190099 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2019
Decision Date	March 15, 2019
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF