FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15— 510(k) K090116

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K090116 for FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15, Substantially Equivalent on 2009-04-22. Applicant: Fujinon, Inc..

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2009-01-21
Decision date: 2009-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kita- Ku Saitama, JP

Download summary PDF View on FDA.gov ↗

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.