MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES— 510(k) K100700

Substantially Equivalent

Benlan, Inc.

FDA 510(k) clearance K100700 for MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES, Substantially Equivalent on 2010-12-13. Applicant: Benlan, Inc..

Clearance details

Applicant: Benlan, Inc.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2010-03-12
Decision date: 2010-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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.