OPTUS LARYNGOSCOPES— 510(k) K945269

Substantially Equivalent

Optus, Inc.

FDA 510(k) clearance K945269 for OPTUS LARYNGOSCOPES, Substantially Equivalent on 1994-11-07. Applicant: Optus, Inc..

Clearance details

Applicant: Optus, Inc.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-10-28
Decision date: 1994-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

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Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.