BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System— 510(k) K150891

Substantially Equivalent

Covidien, LLC( Formerly Beacon Endoscopic Corp.)

FDA 510(k) clearance K150891 for BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System, Substantially Equivalent on 2015-05-01. Applicant: Covidien, LLC( Formerly Beacon Endoscopic Corp.).

Clearance details

Applicant: Covidien, LLC( Formerly Beacon Endoscopic Corp.)
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2015-04-02
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

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.