IRRIGATION & ASPIRATION/VITRECTOMY DEVICE— 510(k) K862188

Name: FDA 510(k) clearance K862188
Creator: U.S. Food and Drug Administration
Published: 1986-08-21

Substantially Equivalent

Coburn Optical Ind., Inc.

FDA 510(k) clearance K862188 for IRRIGATION & ASPIRATION/VITRECTOMY DEVICE, Substantially Equivalent on 1986-08-21. Applicant: Coburn Optical Ind., Inc.. Device class: 2.

Clearance details

Applicant: Coburn Optical Ind., Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1986-06-09
Decision date: 1986-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.