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FDA 510(k)

iStent infinite Trabecular Micro-Bypass System, Model iS3

K-Number: K220032 · 2022-08-02

ApplicantGlaukos Corporation
Decision Date2022-08-02
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

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.

NCT06066645Travoprost Intraocular Implant + iStent InfiniteRECRUITINGNCT07629557Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for KeratoconusRECRUITING

Other records listing Glaukos Corporation as applicant

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.

PMA P080030Intraocular pressure lowering implantPMA P170043Intraocular pressure lowering implantK212797iPrime Viscodelivery System

Related Devices (Code: KYF)

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.

K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, Inc.K162060Ahmed Glaucoma ValveNew World Medical, Inc.

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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