GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR— 510(k) K053410

Substantially Equivalent

Kendall

FDA 510(k) clearance K053410 for GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR, Substantially Equivalent on 2006-01-06. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code FEG
Advisory panel: Gastroenterology, Urology
Date received: 2005-12-07
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code FEG

product code FEG

Death: 2
Total: 2

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.