GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I— 510(k) K032177

Name: FDA 510(k) clearance K032177
Creator: U.S. Food and Drug Administration
Published: 2003-10-02

Substantially Equivalent

Olympus Opto-Electronics Co., Ltd.

FDA 510(k) clearance K032177 for GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I, Substantially Equivalent on 2003-10-02. Applicant: Olympus Opto-Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Olympus Opto-Electronics Co., Ltd.
Product code: Code FDS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-07-16
Decision date: 2003-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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K031256 — XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE2003-07-23

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.