Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)— 510(k) K253468

Name: FDA 510(k) clearance K253468
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Substantially Equivalent

Nova 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.

Clearance details

Applicant: Nova Eye, Inc.
Product code: Code MPA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-10-09
Decision date: 2026-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.