ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE— 510(k) K130611

Substantially Equivalent

Xeridiem Medical Devices

FDA 510(k) clearance K130611 for ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE, Substantially Equivalent on 2013-12-19. Applicant: Xeridiem Medical Devices.

Clearance details

Applicant: Xeridiem Medical Devices
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-07
Decision date: 2013-12-19
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.