K172734

Substantially Equivalent

Single Use Electrosurgical Snare SD-400

Applicant: Olympus Medical Systems Corp.
Product code: FDI
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-11
Decision date: 2017-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.