Clearance Summary
EzVu Visual Vasopressor injector (EV-19) received FDA 510(k) clearance under submission number K241595, sponsored by Veol Medical Technologies Pvt , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-02-27.
- Submission: K241595
- Applicant / Sponsor: Veol Medical Technologies Pvt , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-02-27
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.