SYSTEMS PLUS— 510(k) K860014

Substantially Equivalent

United Surgical Corp.

FDA 510(k) clearance K860014 for SYSTEMS PLUS, Substantially Equivalent on 1986-03-05. Applicant: United Surgical Corp..

Clearance details

Applicant: United Surgical Corp.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1986-01-03
Decision date: 1986-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.