MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM— 510(k) K911998

Name: FDA 510(k) clearance K911998
Creator: U.S. Food and Drug Administration
Published: 1991-07-26

Substantially Equivalent

Allergan Medical Optics

FDA 510(k) clearance K911998 for MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM, Substantially Equivalent on 1991-07-26. Applicant: Allergan Medical Optics. Device class: 2.

Clearance details

Applicant: Allergan Medical Optics
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1991-04-29
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anasco, PR, 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.