OCUSYSTEM IIE— 510(k) K926381

Substantially Equivalent

Surgeon Design

FDA 510(k) clearance K926381 for OCUSYSTEM IIE, Substantially Equivalent on 1993-12-06. Applicant: Surgeon Design.

Clearance details

Applicant: Surgeon Design
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1992-12-22
Decision date: 1993-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.