Cleared Special

K113526 - CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

K113526 is an FDA 510(k) clearance for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, manufactured by Medos International SARL. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 78-day FDA review.

K113526 · Medos International SARL · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
78d
Days
Class 2
Risk

K113526 is an FDA 510(k) clearance for the CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113526

510(k) Number K113526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date February 16, 2012
Days to Decision 78 days
Submission Type Special
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
71d faster than avg
Panel avg: 149d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K113526.
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · Medtronic Neurosurgery · Feb 2013
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc. · Aug 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560 · Medtronic Neurosurgery · Nov 2011
AESCULAP- MEITHKE SHUNT SYSTEM
K110206 · Aesculap, Inc. · Oct 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156 · Medos International SARL · Oct 2011
K113526 · CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
Download PDF FDA Summary Medos International S…