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FDA 510(k)

EXPRESS MINI GLAUCOMA SHUNT

K-Number: K030350 · 2003-03-13

ApplicantOptonol, Ltd.
Decision Date2003-03-13
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EXPRESS MINI GLAUCOMA SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Optonol, Ltd.. It received FDA 510(k) clearance on 2003-03-13 under 510(k) number K030350. 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 EXPRESS MINI GLAUCOMA SHUNT?

EXPRESS MINI GLAUCOMA SHUNT is a medical device that received FDA 510(k) clearance on 2003-03-13. The listed applicant is Optonol, Ltd.. The 510(k) number is K030350.

When did EXPRESS MINI GLAUCOMA SHUNT receive FDA 510(k) clearance?

EXPRESS MINI GLAUCOMA SHUNT received FDA 510(k) clearance on 2003-03-13, under 510(k) number K030350.

Who is the listed applicant for EXPRESS MINI GLAUCOMA SHUNT?

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

What is the FDA product code for EXPRESS MINI GLAUCOMA SHUNT?

The FDA product code for EXPRESS MINI GLAUCOMA SHUNT is KYF.

Related Clinical Trials

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Other records listing Optonol, Ltd. 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.

K012852EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS

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.

K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos CorporationK182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, 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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