Clearance Summary
Ez Catch Auto; Ez Catch YR; Ez Catch TR received FDA 510(k) clearance under submission number K240205, 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 2024-04-15.
- Submission: K240205
- 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: 2024-04-15
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.