K250296

Substantially Equivalent

Disposable Distal Attachment D-201 Series

Applicant: Olympus Medical Systems Corp.
Product code: FDS
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-31
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

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.