510(k) K222584— EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100

Substantially Equivalent

Olympus Medical Systems Corporation

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-26
Decision date: 2023-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.