NEXT GENERATION SALEM SUMP— 510(k) K040388

Substantially Equivalent

Kendall

FDA 510(k) clearance K040388 for NEXT GENERATION SALEM SUMP, Substantially Equivalent on 2004-05-17. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code FEG
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-17
Decision date: 2004-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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.