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ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

by Nova Eye Inc. (Business Name Nova Eye Medical)

510(k) K221872

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221872↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK221872 Date30 Mar 2023ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MPA
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System is a device used for canaloplasty procedures. It combines pressurized viscodilation with catheterization over the entire 360º of the conventional outflow pathway to treat open-angle glaucoma.

This device is supplied as part of a system and is authorized under FDA 510K, MDD, and MDR regulations. It is designed for use in canaloplasty procedures and is manufactured by Nova Eye Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ITrack Advance Canaloplasty Microcatheter used for?

    The ITrack Advance Canaloplasty Microcatheter is used for canaloplasty procedures to treat open-angle glaucoma by combining pressurized viscodilation with catheterization over the entire 360º of the conventional outflow pathway.

  • How is the ITrack Advance Canaloplasty Microcatheter supplied?

    The device is supplied as part of a system that includes the microcatheter with an advanced delivery system specifically designed for canaloplasty procedures.

  • What regulatory approvals does the ITrack Advance Canaloplasty Microcatheter have?

    The device is authorized under FDA 510K, MDD, and MDR regulations, indicating it meets specific regulatory requirements for safety and performance.

  • Is the ITrack Advance Canaloplasty Microcatheter reusable or single-use?

    The device data does not specify whether the microcatheter is reusable or single-use, so this information would need to be obtained directly from the manufacturer.

  • What sizes and models of the ITrack Advance Canaloplasty Microcatheter are available?

    The device data does not provide information about available sizes or models of the ITrack Advance Canaloplasty Microcatheter.