CHARLES/MCINTYRE GIANT BREAK TABLE— 510(k) K841115

Substantially Equivalent

Surgi-Quip Inc.U

FDA 510(k) clearance K841115 for CHARLES/MCINTYRE GIANT BREAK TABLE, Substantially Equivalent on 1984-05-09. Applicant: Surgi-Quip Inc.U.

Clearance details

Applicant: Surgi-Quip Inc.U
Product code: Code FQO
Advisory panel: General, Plastic Surgery
Date received: 1984-03-15
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.