Cleared Traditional

K052386 - MEDTRONIC M2 MAGNET ADJUSTMENT TOOL

K052386 is the FDA 510(k) clearance for MEDTRONIC M2 MAGNET ADJUSTMENT TOOL by Medtronic Neurosurgery. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 176
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