Clearance Summary
iTind System received FDA 510(k) clearance under submission number K210138, sponsored by Medi-Tate , 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 2021-06-25.
- Submission: K210138
- Applicant / Sponsor: Medi-Tate , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5510
- Decision date: 2021-06-25
Classification & Regulation
This clearance is catalogued under FDA product code QKA and 21 CFR 876.5510, within the Gastroenterology, Urology review panel as a Class II device.