Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port— 510(k) K180622

Substantially Equivalent

Covidien

FDA 510(k) clearance K180622 for Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port, Substantially Equivalent on 2018-10-23. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2018-03-09
Decision date: 2018-10-23
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.