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FDA 510(k)

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

K-Number: K012852 · 2002-03-26

ApplicantOptonol, Ltd.
Decision Date2002-03-26
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS is the device name listed in this FDA 510(k) record. The listed applicant is Optonol, Ltd.. It received FDA 510(k) clearance on 2002-03-26 under 510(k) number K012852. 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 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS?

EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS is a medical device that received FDA 510(k) clearance on 2002-03-26. The listed applicant is Optonol, Ltd.. The 510(k) number is K012852.

When did EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS receive FDA 510(k) clearance?

EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS received FDA 510(k) clearance on 2002-03-26, under 510(k) number K012852.

Who is the listed applicant for EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS?

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

The FDA product code for EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS 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.

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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.

K030350EXPRESS MINI GLAUCOMA SHUNT

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.

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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.

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