OPHTHALMIC TIP & BLADE SCALPELS— 510(k) K874057

Substantially Equivalent

Myocure, Inc.

FDA 510(k) clearance K874057 for OPHTHALMIC TIP & BLADE SCALPELS, Substantially Equivalent on 1987-12-23. Applicant: Myocure, Inc..

Clearance details

Applicant: Myocure, Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1987-10-05
Decision date: 1987-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

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.