FIBEROPTIC LARYNGOSCOPE HANDLE— 510(k) K944686

Substantially Equivalent

Fiberoptic Medical Products, Inc.

FDA 510(k) clearance K944686 for FIBEROPTIC LARYNGOSCOPE HANDLE, Substantially Equivalent on 1994-11-04. Applicant: Fiberoptic Medical Products, Inc..

Clearance details

Applicant: Fiberoptic Medical Products, Inc.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-09-23
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, 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.