K253468
- 510(k) number
- K253468
- Device name
- Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- Applicant
- Nova Eye, Inc. CA · US
- Product code
- MPA — Endoilluminator
- Decision date
- 2026-08-10
- Date received
- 2025-10-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253468.pdf
Official FDA record: K253468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.