ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE— 510(k) K130674

Substantially Equivalent

Xeridiem Medical Devices

FDA 510(k) clearance K130674 for ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE, Substantially Equivalent on 2014-01-13. Applicant: Xeridiem Medical Devices.

Clearance details

Applicant: Xeridiem Medical Devices
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-13
Decision date: 2014-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, 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.