510(k) K001241— EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I

Substantially Equivalent

The Olympus Optical Co.

Clearance details

Applicant: The Olympus Optical Co.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-18
Decision date: 2000-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.