XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE— 510(k) K031256

Substantially Equivalent

Olympus Opto-Electronics Co., Ltd.

FDA 510(k) clearance K031256 for XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE, Substantially Equivalent on 2003-07-23. Applicant: Olympus Opto-Electronics Co., Ltd..

Clearance details

Applicant: Olympus Opto-Electronics Co., Ltd.
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-21
Decision date: 2003-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.