K060923

Substantially Equivalent

NAVIAID BGE DEVICE, MODEL 21-001

Applicant: Smart Medical Systems , Ltd.
Product code: FDA
Advisory panel: Gastroenterology, Urology
Date received: 2006-04-04
Decision date: 2006-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.