FDA 510(k)

Duet External Drainage and Monitoring System (EDMS)

K-Number: K243676 · 2025-03-10

Decision Date2025-03-10

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Duet External Drainage and Monitoring System (EDMS) is a medical device manufactured by Medtronic Neurosurgery. It received FDA 510(k) clearance on 2025-03-10 under approval number K243676. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Duet External Drainage and Monitoring System (EDMS)?

Duet External Drainage and Monitoring System (EDMS) is a medical device that received FDA 510(k) clearance on 2025-03-10. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K243676.

When was Duet External Drainage and Monitoring System (EDMS) approved by the FDA?

Duet External Drainage and Monitoring System (EDMS) received FDA 510(k) clearance on 2025-03-10, under approval number K243676.

What company makes Duet External Drainage and Monitoring System (EDMS)?

Duet External Drainage and Monitoring System (EDMS) is manufactured by Medtronic Neurosurgery.

What is the FDA product code for Duet External Drainage and Monitoring System (EDMS)?

The FDA product code for Duet External Drainage and Monitoring System (EDMS) is JXG.

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Other Devices by Medtronic Neurosurgery

K161370Durepair Dura Regeneration Matrix K152700StrataMR Valves and Shunts K181622StrataMR guider tool K212641StrataMR II Valves and Shunts K242034Duet External Drainage and Monitoring System (EDMS)

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.