BAERVELDT GLAUCOMA IMPLANT— 510(k) K905129

Name: FDA 510(k) clearance K905129
Creator: U.S. Food and Drug Administration
Published: 1991-02-11

Substantially Equivalent

Wright Medical Corp.

FDA 510(k) clearance K905129 for BAERVELDT GLAUCOMA IMPLANT, Substantially Equivalent on 1991-02-11. Applicant: Wright Medical Corp.. Device class: 2.

Clearance details

Applicant: Wright Medical Corp.
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 1990-11-14
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peapack, NJ, US

Download summary PDF View on FDA.gov ↗

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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.