SONOPSY— 510(k) K013109

Substantially Equivalent

Hakko Medical Co., Ltd.

FDA 510(k) clearance K013109 for SONOPSY, Substantially Equivalent on 2002-03-12. Applicant: Hakko Medical Co., Ltd..

Clearance details

Applicant: Hakko Medical Co., Ltd.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-17
Decision date: 2002-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meguro-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.