AUTOMATED VITRECTOMY DEVICE— 510(k) K961078

Name: FDA 510(k) clearance K961078
Creator: U.S. Food and Drug Administration
Published: 1996-06-14

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K961078 for AUTOMATED VITRECTOMY DEVICE, Substantially Equivalent on 1996-06-14. Applicant: Promex, Inc.. Device class: 2.

Clearance details

Applicant: Promex, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1996-03-18
Decision date: 1996-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.