NAVIAID BGE DEVICE, MODEL 21-001— 510(k) K060923

Name: FDA 510(k) clearance K060923
Creator: U.S. Food and Drug Administration
Published: 2006-08-15

Substantially Equivalent

Smart Medical Systems , Ltd.

FDA 510(k) clearance K060923 for NAVIAID BGE DEVICE, MODEL 21-001, Substantially Equivalent on 2006-08-15. Applicant: Smart Medical Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Smart Medical Systems , Ltd.
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-04-04
Decision date: 2006-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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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.