K911480

Substantially Equivalent

FLEXIBLE CHOLEDOCHOSCOPE

Applicant: United States Endoscopy Group, Inc.
Product code: FBN
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-04
Decision date: 1991-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.