VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY— 510(k) K844715

Name: FDA 510(k) clearance K844715
Creator: U.S. Food and Drug Administration
Published: 1985-01-22

Substantially Equivalent

Optical Micro Systems, Inc.

FDA 510(k) clearance K844715 for VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY, Substantially Equivalent on 1985-01-22. Applicant: Optical Micro Systems, Inc.. Device class: 2.

Clearance details

Applicant: Optical Micro Systems, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1984-11-27
Decision date: 1985-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.