TRABECULO-SUPRACHOROIDAL SHUNT— 510(k) K902296

Substantially Equivalent

Visionex, Inc.

FDA 510(k) clearance K902296 for TRABECULO-SUPRACHOROIDAL SHUNT, Substantially Equivalent on 1991-03-14. Applicant: Visionex, Inc..

Clearance details

Applicant: Visionex, Inc.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 1990-05-22
Decision date: 1991-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.