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FDA 510(k)

Duet External Drainage and Monitoring System (EDMS)

K-Number: K242034 · 2024-10-24

ApplicantMedtronic Neurosurgery
Decision Date2024-10-24
Product CodePCB
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 2024-10-24 under approval number K242034. The device is classified under product code PCB. 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 2024-10-24. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K242034.

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 2024-10-24, under approval number K242034.

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 PCB.

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Related PubMed Literature

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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 K243676Duet External Drainage and Monitoring System (EDMS)

Official Source

View on FDA Database →

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

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