EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z— 510(k) K011151

Substantially Equivalent

The Olympus Optical Co.

FDA 510(k) clearance K011151 for EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z, Substantially Equivalent on 2001-05-15. Applicant: The Olympus Optical Co..

Clearance details

Applicant: The Olympus Optical Co.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-16
Decision date: 2001-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

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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.