FDA 510(k)

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

Número K: K253468 · 2026-08-10

Data da decisão2026-08-10

Código do produtoMPA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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