Cleared Traditional

K052386 - MEDTRONIC M2 MAGNET ADJUSTMENT TOOL

K052386 is an FDA 510(k) clearance for MEDTRONIC M2 MAGNET ADJUSTMENT TOOL, 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 107-day FDA review.

K052386 · Medtronic Neurosurgery · Neurology device
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Dec 2005
Decision
107d
Days
Class 2
Risk

K052386 is an FDA 510(k) clearance for the MEDTRONIC M2 MAGNET ADJUSTMENT TOOL. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 107 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 - K052386

510(k) Number K052386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date December 16, 2005
Days to Decision 107 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
41d faster than avg
Panel avg: 148d · This submission: 107d
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 225
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K052386.
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
K060681 · Medtronic Neurosurgery · Sep 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K053107 · Codman & Shurtleff, Inc. · Jan 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K053350 · Codman & Shurtleff, Inc. · Jan 2006
CODMAN VPV SYSTEM, MODEL 82-3192
K050739 · Codman & Shurtleff, Inc. · Jul 2005
MEDTRONIC STRATAVARIUS
K041992 · Medtronic Neurosurgery · Jan 2005
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · Integra LifeSciences Corporation · Dec 2004