Cleared Traditional

K123524 - MEDTRONIC STRATA NSC LUMBOPERITONEAL VA...

K123524 is the FDA 510(k) clearance for MEDTRONIC STRATA NSC LUMBOPERITONEAL VA... by Medtronic Neurosurgery. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K123524 · Medtronic Neurosurgery · Neurology device
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Feb 2013
Decision
90d
Days
Class 2
Risk

K123524 is an FDA 510(k) clearance for the MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM. 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 February 13, 2013 after a review of 90 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 K123524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2012
Decision Date February 13, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 157
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K123524.
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K140722 · Integra LifeSciences Corporation · Jan 2015
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc. · Aug 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL · Feb 2012