XCHF-T160 VIDEOSCOPE— 510(k) K082576

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K082576 for XCHF-T160 VIDEOSCOPE, Substantially Equivalent on 2008-10-21. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-05
Decision date: 2008-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.