FDA 510(k)

iStent infinite Trabecular Micro-Bypass System, Model iS3

K-Number: K220032 · 2022-08-02

Decision Date2022-08-02

Product CodeKYF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Glaukos Corporation. The 510(k) number is K220032.

When was iStent infinite Trabecular Micro-Bypass System, Model iS3 approved by the FDA?

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

What company makes iStent infinite Trabecular Micro-Bypass System, Model iS3?

iStent infinite Trabecular Micro-Bypass System, Model iS3 is manufactured by Glaukos Corporation.

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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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.