K032092

Substantially Equivalent

OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

Applicant: Olympus Optical Co., Ltd.
Product code: FCL
Advisory panel: Gastroenterology, Urology
Date received: 2003-07-07
Decision date: 2003-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nishitama-Gun Tokyo, JP

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.