DR.500O OPERATING TABLE— 510(k) K864295

Substantially Equivalent

Koken Mfg Company, Inc.

FDA 510(k) clearance K864295 for DR.500O OPERATING TABLE, Substantially Equivalent on 1986-11-19. Applicant: Koken Mfg Company, Inc..

Clearance details

Applicant: Koken Mfg Company, Inc.
Product code: Code FQO
Advisory panel: General, Plastic Surgery
Date received: 1986-10-31
Decision date: 1986-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.