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FDA 510(k)

TRABECULO-SUPRACHOROIDAL SHUNT

K-Number: K902296 · 1991-03-14

ApplicantVisionex, Inc.
Decision Date1991-03-14
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRABECULO-SUPRACHOROIDAL SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Visionex, Inc.. It received FDA 510(k) clearance on 1991-03-14 under 510(k) number K902296. 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 TRABECULO-SUPRACHOROIDAL SHUNT?

TRABECULO-SUPRACHOROIDAL SHUNT is a medical device that received FDA 510(k) clearance on 1991-03-14. The listed applicant is Visionex, Inc.. The 510(k) number is K902296.

When did TRABECULO-SUPRACHOROIDAL SHUNT receive FDA 510(k) clearance?

TRABECULO-SUPRACHOROIDAL SHUNT received FDA 510(k) clearance on 1991-03-14, under 510(k) number K902296.

Who is the listed applicant for TRABECULO-SUPRACHOROIDAL SHUNT?

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

What is the FDA product code for TRABECULO-SUPRACHOROIDAL SHUNT?

The FDA product code for TRABECULO-SUPRACHOROIDAL SHUNT 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 Visionex, Inc. 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.

K881515TEAR VOLUME TESTS

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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