Duet External Drainage and Monitoring System (EDMS)— 510(k) K243676

Name: FDA 510(k) clearance K243676
Creator: U.S. Food and Drug Administration
Published: 2025-03-10

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K243676 for Duet External Drainage and Monitoring System (EDMS), Substantially Equivalent on 2025-03-10. Applicant: Medtronic Neurosurgery. Device class: 2.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 2024-11-27
Decision date: 2025-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.