Duet External Drainage and Monitoring System (EDMS)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K243676 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Neurosurgery →

• What is the Duet External Drainage and Monitoring System (EDMS) primarily used for in clinical settings?

  The Duet EDMS is designed for the short-term external drainage and monitoring of cerebrospinal fluid (CSF) from either ventricular or lumbar areas in patients. It helps caregivers manage CSF pressure and drainage while providing real-time monitoring through its rotating pressure scale and Clear Site™ Laser Level for accuracy.

• Is the Duet EDMS intended for single-use or reusable applications, and how should it be handled?

  The Duet EDMS is explicitly supplied as a non-sterile, reusable device, intended for use in clinical settings. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed to ensure safety and functionality between uses.

• Does the Duet EDMS come with any special features to ensure accurate CSF monitoring?

  Yes, the Duet EDMS includes a rotating pressure scale for both ventricular and lumbar use, as well as a Clear Site™ Laser Level, which helps caregivers achieve precise drainage and monitoring of cerebrospinal fluid pressure.

• What regulatory pathway was followed for FDA clearance of the Duet EDMS?

  The Duet EDMS received FDA 510(k) clearance (K243676) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It is classified as a Class II medical device under FDA regulation number 882.5550 and was reviewed by the Neurology (NE) Advisory Committee.

• Are there any specific storage requirements mentioned for the Duet EDMS?

  The provided data does not specify any storage requirements for the Duet EDMS. Since it is reusable and non-sterile, facilities should follow general medical device storage guidelines to maintain functionality and hygiene.