Clearance Summary
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags received FDA 510(k) clearance under submission number K191341, sponsored by Corinth Medtech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-06-13.
- Submission: K191341
- Applicant / Sponsor: Corinth Medtech, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-06-13
Classification & Regulation
This clearance is catalogued under FDA product code FJL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.