OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE— 510(k) K853598

Substantially Equivalent

Myocure, Inc.

FDA 510(k) clearance K853598 for OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE, Substantially Equivalent on 1985-11-04. Applicant: Myocure, Inc..

Clearance details

Applicant: Myocure, Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1985-08-27
Decision date: 1985-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.