TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934— 510(k) K052413

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K052413 for TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934, Substantially Equivalent on 2005-11-17. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2005-09-02
Decision date: 2005-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.