ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System— 510(k) K221872

Name: FDA 510(k) clearance K221872
Creator: U.S. Food and Drug Administration
Published: 2023-03-30

Substantially Equivalent

Nova Eye Inc. (Business Name Nova Eye Medical)

FDA 510(k) clearance K221872 for ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System, Substantially Equivalent on 2023-03-30. Applicant: Nova Eye Inc. (Business Name Nova Eye Medical). Device class: 2.

Clearance details

Applicant: Nova Eye Inc. (Business Name Nova Eye Medical)
Product code: Code MPA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-28
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.