Clear-Tip EUS-FNA— 510(k) K180363

Substantially Equivalent

Finemedix Co., Ltd.

FDA 510(k) clearance K180363 for Clear-Tip EUS-FNA, Substantially Equivalent on 2018-11-01. Applicant: Finemedix Co., Ltd..

Clearance details

Applicant: Finemedix Co., Ltd.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-09
Decision date: 2018-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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.