Cleared Traditional

K243676 - Duet External Drainage and Monitoring System (EDMS)

K243676 is an FDA 510(k) clearance for Duet External Drainage and Monitoring S..., manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K243676 · Medtronic Neurosurgery · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
103d
Days
Class 2
Risk

K243676 is an FDA 510(k) clearance for the Duet External Drainage and Monitoring System (EDMS). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Fort Worth, US). The FDA issued a Cleared decision on March 10, 2025 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Neurosurgery devices

FDA 510(k) Submission Details - K243676

510(k) Number K243676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date March 10, 2025
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 148d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 220
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