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FDA 510(k)

Duet External Drainage and Monitoring System (EDMS)

K-Number: K243676 · 2025-03-10

ApplicantMedtronic Neurosurgery
Decision Date2025-03-10
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Duet External Drainage and Monitoring System (EDMS) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2025-03-10 under 510(k) 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. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K243676.

When did Duet External Drainage and Monitoring System (EDMS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Duet External Drainage and Monitoring System (EDMS)?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Medtronic Neurosurgery as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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