EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N— 510(k) K123317

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K123317 for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N, Substantially Equivalent on 2012-12-11. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-25
Decision date: 2012-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.