OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE— 510(k) K032092

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K032092 for OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE, Substantially Equivalent on 2003-07-16. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: 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

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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.