Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors— 510(k) K143018

Substantially Equivalent

Covidien

FDA 510(k) clearance K143018 for Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors, Substantially Equivalent on 2015-04-02. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2014-10-20
Decision date: 2015-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.