Not Cleared Post-NSE

Medtronic DUET External Drainage and Monitoring System (DEN120017) - FDA 510(k) Clearance

Class II Neurology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN120017 · Medtronic Neurosurgery · Neurology device
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Aug 2014
Decision
609d
Days
Class 2
Risk

DEN120017 is an FDA 510(k) submission (not cleared) for the Medtronic DUET External Drainage and Monitoring System. Classified as External Cerebrospinal Fluid (csf) Diversion (product code PCB), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2014 after a review of 609 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5560 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 609 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Medtronic Neurosurgery devices

Submission Details

510(k) Number DEN120017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 21, 2012
Decision Date August 22, 2014
Days to Decision 609 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
461d slower than avg
Panel avg: 148d · This submission: 609d
Pathway characteristics

Device Classification

Product Code PCB External Cerebrospinal Fluid (csf) Diversion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5560
Definition Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.