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FDA 510(k)

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

K-Number: K253468 · 2026-08-10

ApplicantNova Eye, Inc.
Decision Date2026-08-10
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) is the device name listed in this FDA 510(k) record. The listed applicant is Nova Eye, Inc.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K253468. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)?

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Nova Eye, Inc.. The 510(k) number is K253468.

When did Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) receive FDA 510(k) clearance?

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) received FDA 510(k) clearance on 2026-08-10, under 510(k) number K253468.

Who is the listed applicant for Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)?

The FDA 510(k) record lists Nova Eye, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)?

The FDA product code for Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) is MPA.

Related Devices (Code: MPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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