Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)— 510(k) K253468
Substantially EquivalentNova Eye, Inc.
FDA 510(k) clearance K253468 for Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A), Substantially Equivalent on 2026-08-10. Applicant: Nova Eye, Inc.. Device class: 2.
Summary
Nova Eye's iTrack 250A Canaloplasty Microcatheter is filed under product code MPA, endoilluminators. The record doesn't describe the microcatheter beyond its name.
Class II, 21 CFR 876.1500. The Ophthalmic review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Nova Eye filed from Fremont, California. The substantially equivalent decision came 305 calendar days after receipt (October 9, 2025 to August 10, 2026).
Clearance details
- Applicant
- Nova Eye, Inc.
- Product code
- Product code MPA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code MPA
view all- K242184 — Alcon 27GA Chandelier (8065000252) +2 more
- K233653 — Midfield Light Pipe, 23ga (3269.M06-00) +2 more
- K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
- K202670 — Nam illumination probe with chopper
- K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator
Data sourced from openFDA. This site is unofficial and independent of the FDA.