Cleared Traditional

K153041 - Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

K153041 is an FDA 510(k) clearance for Bundled Neurological Shunts and Accesso..., manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K153041 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
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Mar 2016
Decision
147d
Days
Class 2
Risk

K153041 is an FDA 510(k) clearance for the Bundled Neurological Shunts and Accessories Product Families Labeling Modific.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on March 14, 2016 after a review of 147 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 Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K153041

510(k) Number K153041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2015
Decision Date March 14, 2016
Days to Decision 147 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
1d faster than avg
Panel avg: 148d · This submission: 147d
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
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K153041.
Smart External Drain (SED) System
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StrataMR Valves and Shunts
K152700 · Medtronic Neurosurgery · Apr 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897 · Integra LifeSciences Corporation · Mar 2016
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
K150898 · Moller Medical GmbH · Dec 2015
Codman Certas Plus Programmable Valve
K152152 · Medos International SARL · Oct 2015