X-FLO— 510(k) K800110

Name: FDA 510(k) clearance K800110
Creator: U.S. Food and Drug Administration
Published: 1980-02-06

Substantially Equivalent

Contemporary Surgical Systems, Inc.

FDA 510(k) clearance K800110 for X-FLO, Substantially Equivalent on 1980-02-06. Applicant: Contemporary Surgical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Contemporary Surgical Systems, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1980-01-16
Decision date: 1980-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.