Kangaroo Feeding Tube with IRIS Technology— 510(k) K163002

Substantially Equivalent

Covidien (Dba Medtronic)

FDA 510(k) clearance K163002 for Kangaroo Feeding Tube with IRIS Technology, Substantially Equivalent on 2017-05-16. Applicant: Covidien (Dba Medtronic).

Clearance details

Applicant: Covidien (Dba Medtronic)
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2016-10-28
Decision date: 2017-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.