EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)— 510(k) K230909

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K230909 for EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22), Substantially Equivalent on 2023-05-30. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-31
Decision date: 2023-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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.