FDA 510(k)

iStent infinite Trabecular Micro-Bypass System, Model iS3

Número K: K220032 · 2022-08-02

Data da decisão2022-08-02

Código do produtoKYF

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

iStent infinite Trabecular Micro-Bypass System, Model iS3 is the device name listed in this FDA 510(k) record. The listed applicant is Glaukos Corporation. It received FDA 510(k) clearance on 2022-08-02 under 510(k) number K220032. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iStent infinite Trabecular Micro-Bypass System, Model iS3?

iStent infinite Trabecular Micro-Bypass System, Model iS3 is a medical device that received FDA 510(k) clearance on 2022-08-02. The listed applicant is Glaukos Corporation. The 510(k) number is K220032.

When did iStent infinite Trabecular Micro-Bypass System, Model iS3 receive FDA 510(k) clearance?

iStent infinite Trabecular Micro-Bypass System, Model iS3 received FDA 510(k) clearance on 2022-08-02, under 510(k) number K220032.

Who is the listed applicant for iStent infinite Trabecular Micro-Bypass System, Model iS3?

The FDA 510(k) record lists Glaukos Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iStent infinite Trabecular Micro-Bypass System, Model iS3?

The FDA product code for iStent infinite Trabecular Micro-Bypass System, Model iS3 is KYF.

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