BAERVELT PARS PLANA GLAUCOMA IMPLANT— 510(k) K955455

Name: FDA 510(k) clearance K955455
Creator: U.S. Food and Drug Administration
Published: 1997-02-18

Substantially Equivalent

Pharmacia Iovision, Inc.

FDA 510(k) clearance K955455 for BAERVELT PARS PLANA GLAUCOMA IMPLANT, Substantially Equivalent on 1997-02-18. Applicant: Pharmacia Iovision, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia Iovision, Inc.
Product code: Code KYF
Device class: Class 2
Regulation: 21 CFR 886.3920
Advisory panel: Ophthalmic
Date received: 1995-11-29
Decision date: 1997-02-18
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.