K051886

Substantially Equivalent

OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F

Applicant: Olympus Medical Systems Corporation
Product code: FBN
Advisory panel: Gastroenterology, Urology
Date received: 2005-07-12
Decision date: 2005-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.