Clearance Summary
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System received FDA 510(k) clearance under submission number K221872, sponsored by Nova Eye Inc. (Business Name Nova Eye Medical). The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-03-30.
- Submission: K221872
- Applicant / Sponsor: Nova Eye Inc. (Business Name Nova Eye Medical)
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-03-30
Classification & Regulation
This clearance is catalogued under FDA product code MPA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.