AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE— 510(k) K100526

Substantially Equivalent

Kentec Medical, Inc.

FDA 510(k) clearance K100526 for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE, Substantially Equivalent on 2010-04-22. Applicant: Kentec Medical, Inc..

Clearance details

Applicant: Kentec Medical, Inc.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2010-02-24
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.